. 2023 Dec 20;38(2):554–585. doi: 10.1007/s00464-023-10554-4

Table 1.

Robotic systems description and evaluation

Robotic system	Origin and use	Price	Regulatory approval and indications	Device description	Training pathways	IDEAL Framework Stage and evidence
da Vinci, Intuitive Surgical, Inc [16].* Figure 3	USA, 1995 (Intuitive Surgical founded) Launched 1st generation in 2000 after FDA approval for general laparoscopic surgery Merged with ZEUS Robotic Surgical System 2003 1st operation 2000 Systems in use as of 31/12/22: 7,544 systems: 4,563 in the US, 1,388 in Europe, 1,234 in Asia and 359 in the R.O.W Operations performed as of 31/12/22: Estimated 1,875,000 during 2022, and over 10 million in total	Xi ~ $2 million with per procedure costs of roughly $2500 [17] X stated ~ $1.2 million in SSI Mantra technology differentiator brochure	Approvals: CE mark, FDA, Japanese Ministry of Health, Labour & Welfare (MHLW) 2012, China National Health Commissions 2018, UKCA Mark needed for GB market post June 2023 Indications multiport: General surgery, urology, gynaecology, thoracic, paediatrics, plastics, head and neck specialties Indications for SP: Urology, TORS, and expanding	Set up: Master slave with surgeon, patient and vision cart. st generation da Vinci Surgical System 2nd generation da Vinci S 3rd generation da Vinci Si 4th generation Xi, X and single port (SP) Xi: advanced instrumentation, vision, and features e.g. integrated table motion, setup automation allowing target anatomy and positioning guidance. Xi has a boom allowing multi-quadrant access X: cost-conscious options with the same arm architecture as Xi ability for advanced analytics SP: Flexible platform configuration, Single port 25mm cannula insertion holding three instruments and articulated 3D endoscope Vision: 3DHD Instruments: 8mm to 12mm, reusable (12 to 18 uses), has advanced energy and staplers Additional information: Firefly Fluorescence Imaging combined in the endoscope Additional robots include Ion Endoluminal system for minimally invasive biopsies Intuitive Hub System and My Intuitive app to record and track progress. Development of machine learning tools to help improve evaluation (launch stated hopefully 2023) Intuitive offers grants for fellowships and research and development	Training: Established modular training pathways TR100, TR200, TR300, TR400 and TR500 as in-hospital proctors. Includes training with patient cart assistance Virtual reality: Multiple validation studies of simulators [18] (dV-Trainer, da Vinci Skills Simulation from Mimic Technologies™ and da Vinci SimNow™), provide basic and procedure-specific simulation	Multiport—Stage 4 Single Port- Stage 3 Supporting evidence: > 34,000 peer reviewed clinical journals Multiple Studies, including RCTs, show long-term outcome data for multiport [19] Single port in urology systematic review 2021 showed safety [20] and shorter hospital stay/less pain with otherwise comparable outcomes vs multiport in a systematic review and meta-analysis [21, 22] da Vinci Application Programmer Interface via dVLogger recording device provide automated performance metrics which have been evaluated with concurrent [23]– [26], construct [27]– [29] and predictive [29]– [32] validity in some studies, with new research focusing on the application of AI
KANGDUO ROBOT® Surgical System (KD-SR-01), Suzhou Kangduo Robot Co., Ltd Figure 4	China, 2013 Collaborating with University Harbin Institute for Technology Countries in use: China 1st operation: Pyeloplasty 7/8/2020 Currently 20 systems in use	Price: $1–1.4 million	Approvals: National Medicinal Products Administration (NMPA) of China Approval 2022 Approvals in Europe, Russia and Sri Lanka in progress Indications: Urology, gynaecology, general surgery, thoracics	Set up: Similarities to da Vinci: Surgeon, patient and vision cart Foot pedals have the same design as the da Vinci Cross laser positioning system and boom like Xi Filter tremor and motion scaling Differences: Only 3 arms and an open console Instruments: Fourteen 8mm instruments fenestrated grasper, double fenestrated grasper, tip-up double fenestrated grasper, Cadiere forceps, curved dissector, monopolar straight and curved scissors, large and small hook, Maryland bipolar forceps and large/small needle driver, fenestrated bipolar forceps, mini non-invasive round tip fenestrated Reusable up to 10 times Ergonomics: Seated, armrest Vision: 3DHD with glasses, compatible with most 10mm 3D endoscopes Additional: ICG and 4KHD Fluorescence Reconstruction and USS capability 5G remote surgery performed on a live animal successfully Future models SR1500 and SR2000 in development and will include AI capabilities	Training: Training centre in Beijing 1–2 days with animal operating Virtual reality: Co-designed with Simbionix, embedded within the surgeon console	Stage 3 Supporting evidence: Pre-IDEAL (Stage 0)- RCT on porcine models [33] Stage 1: First in human B/L pyeloplasty for horseshoe kidney [34] Stage 2a: Case reports on partial Nephrectomy [35, 36] Prospective single-centre study for pyeloplasty [37] Stage 2b: Prospective single arm studies for RARP [38], partial adrenalectomy [39], pyeloplasty comparing to da Vinci Si, da Vinci outperformed in operative time and time per stitch [40] Stage 3: RARP- KangDuo vs da Vinci Si, comparable short-term functional and oncological outcomes [41] 2 centre blinded RCT showing non-inferiority with da Vinci Si in RAPN for T1a renal tumours [42]
Senhance® Surgical Robotic System, Asensus Surgical Inc Figure 5	USA, 2013–2016 developed and known as Telelap ALF-X. 2016 Launched with TransEnterix which became Asensus Surgical in 2021 1st Operation: Hysterectomy, Rome, Italy [43] Use: 10,000 + operations worldwide 39 clinical sites US, Europe and Asia 6 global training centres 250 + active surgeon users	$1–1.2 million with per procedure costs ~ $1000 [17] Benign hysterectomy: Procedure cost $1,393 da Vinci, $559 Senhance, laparoscopic $498 [44]	Approvals: FDA and CE mark 2017 MHLW 2019 Further CE mark, FDA, MHLW approval for machine vision and augmented intelligence 2023 Indications: Urology, General Surgery, Thoracic, Gynaecology, Paediatrics	Set up: Open console from the surgeon’s cockpit Modular system: Four manipulator arms (Japan and CE Markets only) are standalone units with digital fulcrum point; therefore, no docking to minimise trauma and increase workspace at the trocar Hand controller as a laparoscopic instrument Ergonomics: Seated in the surgeon’s cockpit, adjustable settings Instruments: Reusable, most are laparoscopic (non-articulated) 5mm bipolar grasper and needle driver are articulated Hand/instrument movements are traditionally laparoscopic Haptic feedback- an enhanced sense of force pressure and tension 3mm, 5mm and 10mm instruments. 70 + types, including advanced ultrasonic device Vision: 3DHD with glasses Eye tracking device, supplied by Tobii, is activated by the surgeon and moves the camera to the point of vision Portability: Easily portable due to bedside unit arms i.e. modular units Additional: Open platform architecture to be compatible with 3DHD and HD fluorescence systems, negating the need for software updates, as well as electrocautery units currently in the hospital, improving the economic feasibility Machine vision/augmented intelligence- Intelligent Surgical Unit (ISU). Current capabilities include the automatic following of the tip of the instrument, smart zoom if you have a degreed scope keeping the image centred on relevant operative anatomy, and real-time, point-to-point and contour measurement allowing for example mesh sizing. In development: 3D mapping, instrument recognition, organ/critical structure detection	Training: Whole team training 2 day dry and 1 day wet lab in Milan or Amsterdam. Scheduled case the week after for surgical proctor to attend the surgeon’s hospital, with a clinical specialist to support until fully independent	Stage 3 Supporting evidence: Clinical evidence, 80 + reviewed publications, for 8 years, multicentre, multispecialty observational studies including from The TransEnterix European Patient Registry for Robotic-Assisted Laparoscopic Procedures in Urology, Abdominal, Thoracic, and Gynaecologic Surgery ("TRUST"). It is the largest multi-specialty robot-assisted laparoscopy registry. 2500 + patients enrolled Safety and efficacy with low conversion and low complication rate from publications [45]
hinotori™ Surgical Robot System, Medicaroid Corporation** Figure 6	Japan, 2013 Jointly established by Kawasaki Heavy Industries Ltd., and Sysmex Corporation 1st operation: December 2020	Not publicly available, states less than the equivalent 270 million yen of da Vinci Xi	Approvals: Japanese Ministry of Health Labour & Welfare (MHLW) approval in August 2020 Indication and use in: Urology, General Surgery- gastrectomy 2022 [46], colorectal [47] and gynaecology [48]	Set up: “Operation unit” with 4 arms, 3 instruments and 1 endoscope holder on an “arm base” boom “Surgical cockpit” has a 3D viewer, touch panel, hand control grips and foot unit similar to Intuitive’s design Compact and safety design to minimise collisions and detect arm/port movement errors (Cubic-S), plus a vibration filtration The pivot point position of the trocar on the patient’s body wall is monitored by Cubic-S. The software allows more workspace around the trocar as the arms do not dock to the trocar, therefore, there is a reduced risk of clashing with the patient or robotic arms Robotic function can be enabled at the arm, operation cart panel or when the surgeon looks into the viewer Ergonomics: Adjustable settings at the surgical cockpit Vision: 3D HD Instruments: Sterilisation with autoclave. Can be used up to 10 times Portability: Compact, easily transferable between ORs Additional: Designed to be 5G compatible, anticipating telesurgery/remote operating, with an initial animal cadaver feasibility study showing safety in 2022 [49]	Training: The whole healthcare team at Kobe University Hospital International Clinical Cancer Research Centre	Stage 2b Supporting evidence: Single centre prospective study 30 patients for RAPN [50] and a multicentre study of 30 patients for RARP [51]
Hugo™ RAS System, Medtronic* Figure 7	USA, Launched 2021 Countries in use: Australia, Belgium, Brazil, Canada, Chile, Denmark, Finland, France, Germany, India, Israel, Italy, Japan, Netherlands, Panama, Portugal, Spain, Sweden, Taiwan, United Kingdom 1st operation: RARP, Chile 2021 [52]	Price: Stated to be 20–25% cheaper than da Vinci Xi	Approvals: CE mark 2021; Health Canada License; MHLW Japan; Not FDA approved Indications: Urology, gynaecology, general surgery	Set up: Modular, multi-quadrant platform Surgeon console: Open console, pistol grip controllers, with motion scaling variability, compatibility with the Hugo task simulator. Pedals control the arms, energy supply (monopolar, bipolar), master clutch, camera control and arm switching Arm cart: Three and four arm configurations, alternatively one arm can be used to assist in laparoscopic procedures Hugo Tower: Touch screen monitor and central processing unit for the robotic system featuring KARL STORZ technologies, Valleylab™ FT10 energy platform and TouchSurgery™ Enterprise video management and analytics platform Instruments: Standard instruments and monopolar/bipolar. No advanced energy or stapling devices Ergonomics: Seated at surgeon console, adjustable Vision: 3DHD with glasses, endoscope on any arm. Head tracking system which will disable control of the instruments if the surgeon is not looking at the monitor Portability: The modular system is easily portable Additional: Cloud-based surgical video capture option in Touch Surgery record procedures and gather data for viewing and analysis	Training: HUGO ASCEND Training Pathway. Modular training pathway with Technical Training (Medtronic Staff), Procedural Experience (by surgeons), Coaching (Surgeon to surgeon proctoring) Other: Onsite on demand support from engineers Virtual reality: Hugo™ task simulator, like da Vinci backpack simulators, attaches to the surgeon console	Stage 2b Supporting evidence: Stage 0: Report on left and right colectomy in cadavers Jan 2023 [53] Stage 1: Multiple reports of first in-human cases for urology, gynaecology 2022 [52] and general surgery [54, 55] Stage 2a: Case series in urology [56, 57] Stage 2b: 112 patients undergoing RARP [58], 60 patients sacrocolpopexy [59]
MicroHand S Surgical Robot, Shandong WEGO Surgery Robot Co., Ltd. & ZCo Design Co., Ltd.** Figure 8	China, 2013 Developed by Central South University and Tianjin University 1st operation in trial: 2014	Not publicly available	Approvals: NMPA approval 2021 (in certain general surgery procedures) [60]	Set up: “Doctor’s console” is open with an armrest, and finger grip hand controller Patient console has 3 robotic arms Vision: Vision console. 3DHD view Ports: 10mm trocars for the robotic arms Additional: Incorporated 5G to allow remote operating, performing a radical cystectomy [61]		Stage 2b Supporting evidence: Single centre prospective centres: - Lap vs robotic right hemi 22 patients, robotic outperformed [62] - Versus da Vinci 45 patients undergoing sigmoid colectomy. Microhand shorter length of stay and improved hospital costs [63] - Robotic TME vs. da Vinci Si, no difference found in patients’ genitourinary function; both outperformed lap [64] - Other: sleeve gastrectomy (n = 7) [65] and a dry lab exercise showing construct validity of kinematic data on the MicroHand S robot
Revo-I, Meerecompany Inc Figure 9	Republic of Korea, 2007 1^st human trials: Cholecystectomies 2016 [66] 1^st operation (after approvals): RARP 2018 In use: USA, Asia including Uzbekistan, Japan, Europe and R.O.W Number of ops worldwide: 200 + by September 2021	Not publicly available but states a reduced price to be available in more countries	Approvals: Ministry of Food and Drug Safety (MFDS) Approval 2018 Indications: General Surgery, gynaecology, urology, ENT	Set up: Similar to da Vinci Si Master console, vision and patient cart Surgeon console is closed Ergonomics: Seated, adjustable Instruments: 13 instrument types, short and long, 26 in total. Monopolar, bipolar, scissors, forceps, needle holders and clip appliers Vision: 3DHD	Training: Modular training pathway: online, dry/wet lab, procedural skills then robotic skill assessment Supports with logistics, technical, marketing, open R&D, Revo Clinical Support Consultant Virtual reality: Revo-Sim with three modules- basic to advanced including procedural. 30 total tasks	Stage 2b Supporting evidence: Stage 1: First case in human case reports including prostatectomy and pancreatectomy [67] Stage 2a/2b Prospective cohort study 17 patients undergoing RARP [68] Prospective cohort study 15 patients undergoing cholecystectomy [66] Stage 2b: Equivalent short term functional and oncological outcomes in propensity score analysis of 33 in each cohort Revo-I vs da Vinci Si [69]
Toumai® Laparoscopic Surgical Robot (MicroPort® Toumai®) Shanghai MicroPort MedBot (Group) Co., Ltd. (MicroPort® MedBot®)** [70] Figure 10	China, 2014 Design completed 2018 Use: Over 30 Chinese centres	Not publicly available	Approvals: National Medical Products Administration (NMPA), 2022 for Urology Indications: Urology, gynaecology, general surgery, thoracics [71]	Set up: Similar to da Vinci Xi with 4 arms on a boom. Tremor filtration Surgeon, vision and patient console Vision: 3DHD Additional: Incorporated 5G for remote operating [71]. Stating world’s longest range performed (> 5000km) in June 2022 Toumai ® 2^nd generation awaiting NMPA approval Toumai ® single arm commencing enrolment for clinical trials, completed 1^st in human Other product including natural orifice and bronchoscopy developed	Training: 400 + senior surgeons trained, ~ 1500 training procedures complete	Stage 2b Supporting evidence: Clinical validation study of 1st generation, > 300 procedures in urology, gastrointestinal and gynaecology Completed clinical trials for 2nd generation in gynaecology, thoracics and general surgery undergoing registration application phase
Versius®, Cambridge Medical Robotics (CMR) Surgical Figure 11	UK, 2014 1^st Operation: 2019 Use: Over 100 systems installed with over 5000 cases performed (November 2022)	Not publicly available Flexible, bespoke contracts, including subscription/lease/capital purchase models	Approvals: CE mark March 2019 Indications: Adult General surgery, gynaecology, urology, thoracics Contraindications: Paediatrics, Surgery relating to the circulatory or nervous system, radical hysterectomies with early-stage cervical cancer	Set up: Open console, modular system Hand controller likened to a split video game controller Ergonomics: Adjustable settings, armrest, seated or standing Instruments: 6 fully articulated instruments Vision: 3DHD with glasses Portability: Footprint of each bedside unit arm: height 1425 mm/width 380 mm/depth 380 mm, height adjustable, neutral/sleep position is smaller than most average human height. Allows access to the patient Additional: “Soft” or “collaborative” robotics, doesn’t use a pully system like other robotic platforms, it has motors with torque sensors. This allows external force applied to the arm as a safety feature	Training: Modular, whole team training pathway including e-learning (80% pass), dry and wet lab procedure run through Preceptor present to check happy with the robot at the clinical site Additional training offered Virtual reality: Versius Trainer	Stage 2b Supporting evidence: Stage 1/2a: First in human studies of 30 cases included cholecystectomy, appendicectomy, diagnostic laparoscopy, and gynaecological operations [72] Stage 2b: Prospective observational study 32 participants in colorectal [73] Other feasibility and pre-clinical studies are available on their website
MP1000 and SP1000 robots, Shenzen Edge Medical Robotics Co. Figure 12 Note:** Unable to view the website, information has been taken from publications, web reports and draft material which may not accurately reflect the company or the robotic device	China, 2017 Operations in trial: RARP 2021 Nephrectomy 2021 Hysterectomy 2021 Oophorectomy 2021 Distal gastrectomy 2022 Left hemicolectomy 2022 Pneumonectomy 2022	Not publicly available	Approvals: Multiport system MP1000 approved in urological surgery by Chinese National Medical Products Administration (NMPA) in December 2022 [74] Single Port (SP1000) under preclinical trials [74] Likely NMPA approvals in 2023 for other specialties and SP1000 Indications: General surgery urology, gynaecology and thoracics	Set up: Multiport system MP1000 Standard master–slave set-up control with a surgeon, vision and patient cart with a 4-arm structure [75, 76] Single port system SP1000 Same setup, 3 articulating arms with 7 DOF and an endoscope with 5 DOF. Same surgeon console for both robots Photos suggest almost identical setup and controls to da Vinci Xi and da Vinci SP In comparison to da Vinci SP with 4 DOF in endoscope, Edge Medical states 5 DOF Instruments: 30 instruments, bipolar and monopolar Developing Edge Robotic Ultrasonic Shears and Edge Robotic Stapler (stating this may not be successful) [60] Vision: 3DHD Additional: Developing Edge Bronchoscope Robot		Stage 2a Supporting evidence: MP1000 Stage 2a (pending 2b): 1st clinical trial in 2021 [60] Ongoing/finishing gynaecology clinical trial [60] Initiated clinical trials and aimed to finish recruitment November 2022 in general surgery and thoracics SP1000 Stage 0: Pre-clinical safety and feasibility in live porcine for nephrectomy [77] and taTME [78] Stage 1/2a: SP1000 completed the operations of its first clinical trial in gynaecology [60]. A webpage report (May 2022) stated it has performed an in human ovarian cyst removal [79]
Dexter, Distalmotion® Figure 13	Switzerland, 2012 Countries in use: Approval for use in European countries at this time 1^st operation: Rectopexy 2021, Gynaecology 2022, RARP 2022 [80]	Not publicly available	Approval: CE mark 2020 Indications: Urology, gynaecology, general surgery	Set up: Open console, modular system with two instrument arms and a robotic endoscope holder On-demand laparoscopic and robotic platforms as the surgeon is sterile, allowing easy switching between the bedside and surgeon console. Use of traditional laparoscopic port positions The hand controller is a pistol grip with finger and thumb paddles to open/close Two foot pedals for clutch and camera Instruments: Wristed, single-use, provided by Dexter. Five types including Johan, Maryland, monopolar hook, monopolar scissors, and needle holder. Open platform i.e., use of existing hospital laparoscopic tower and endoscope (if 3D) Ergonomics: Fully adjustable to sit or stand Vision: Open platform, 3D with glasses, imaging device agnostic which allows fluorescence imaging to be kept up-to-date as technology advances Portability: Motorised, portable to other ORs	Training: The Dexter Academy™. Modular training; didactic online off and on-site training including dry, wet (cadaver/live animal) Dedicated clinical application specialist per site	Stage 2a Supporting evidence: Stage 1: nephrectomy [81], pelvic organ prolapse [82] Stage 2a: Case series of 30 inguinal hernia repairs [83] and of the first 10 prostatectomies Pending 2b: Recruitment for prospective clinical study ongoing ClinicalTrials.gov Identifier NCT05537727
avatera® system, avateramedical GmbH Figure 14	Germany, 2011 1^st operation RARP, 2022 Countries in use: Germany, Denmark, Greece, France, Hungary and others	Not publicly available ~ €1 million ($1.1) in 2019 [84]	Approval: CE mark 2019 Indications: For use with patients who are eligible for laparoscopic surgical procedures according to the surgeon’s assessment and decision. It has been validated for urologic laparoscopic surgery such as prostatectomy, cystectomy, lymph node removal, ureter surgery and (partial) nephrectomy and gynaecological laparoscopic surgery such as hysterectomy, myomectomy and resection of endometriosis	Set up: 4-arm robotic unit, surgeon control unit and optional electrosurgery cart. Two joystick hand controllers with straps and finger clutches Six-foot pedals for electrosurgery, camera and instrument switch Eyepiece designed to leave ears and mouth uncovered Instruments: Single use (except reusable endoscope), 5mm. Only bipolar available currently Ergonomics: Built-in ergonomic chair, adjustable settings, stereoscopic eyepiece with headrest, ears “free” for communicating Vision: 3D stereoscopic magnified view QXGA resolution (2048 × 1536px), overlay information on instruments, electrosurgery usage, statuses, and alarms Portability: Easily moved by one person between rooms through standard doors Additional highlights: Next generation in development The current system is very quiet within the OR due to no external fans	Modular training is available for the whole team with VR, Dry and wet (animal) lab Proctors available for onsite training with performance evaluation Virtual reality: In system simulation available	Stage 1 Supporting evidence: Stage 0: Feasibility of robotic bilateral nephrectomy and radical cystectomy live porcine models [85, 86] Pending 2b: A current multicentre trial is running and registered on ISRCTN45854742
Mantra Surgical Robotic System, M/S. Sudhir, Srivastava Innovations (SSI) PVT. Ltd* Figure 15	India, 2016 1^st Operation: July 2022 In use: India, Sri Lanka, Nepal, Bangladesh and Indonesia	Price: $625,000	Approvals: CDSCO, India Filing for CE mid 2023 Indications: Cardiothoracic, Urology, General Surgery, Head and Neck, Gynaecology	Set up: Open console, modular 3–5 arm system, foot pedals with arm switch, clutch, camera control and electrocautery Vision cart has live streaming and recording capability for teletraining/telementoring Ergonomics: Seated, adjustable Instruments: 30 + 9mm instruments (SSI MUDRA™) including monopolar, bipolar, and clip appliers. No advanced energy yet Reusable with autoclave sterilisation Developing other instruments Vision: 3DHD, head tracking camera safety feature, articulating endoscope Portability: Modular with bedside units more easily portable, stowed dimensions are 610mm x 450mm x 1640mm Additional: Augmented reality intraoperative 3D holographic representation of patient’s anatomy with accurate MRI/CT scans	Training: Currently only provided in India Virtual reality: SSI Mantra Virtual Reality Simulator	Stage 1 Supporting evidence: Nil published currently, but in clinical use
MIRA Surgical System, Virtual Incision Corp.* Figure 16	USA, 2006 1^st operation: Right hemicolectomy August 2021	N/A currently not for sale	Approvals: The MIRA Surgical System is an Investigational Device and is not currently available for sale Indications: N/A	Minibot and camera: Single port through ~ 2.5cm incision MIRA features two robotic arms and an articulating high-definition camera. Motors are located inside the arms, with the goal of achieving triangulation at sufficient strength and dexterity, even for complex procedures like colon resection The miniaturised design reduces the external footprint, potentially eliminating the need for dedicated OR space. It also enables multi-quadrant access with no external arm collisions Surgeon console: Open console design Hand controls have open-close paddles and sensors to detect the user, with a clutch function in the left hand and a camera function in the right Foot pedals (clutch, camera, left hand bipolar, right hand monopolar) Ergonomics: Seated, open console maintaining peripheral vision of the operating room Vision: Full HD resolution in real-time on the main display Portability: MIRA’s miniaturised design is portable and aims to be easily set up in any operating room in a matter of minutes, eliminating the need for dedicated OR space and long turnover times. The minibot and camera are sterilised between cases like other instruments and stored on the shelf in a sterile tray. Just before the procedure, it is mounted on the patient table with no need for draping or docking Haptic feedback: A haptic indicator detects when instruments are out of range Additional: Surgeon App (MIRA IQ) currently under development	Training: Extensive training will be provided by the company Virtual reality: Simulator (MIRA Sim) currently under development	Stage 1 Supporting evidence: Stage 0: Pre-clinical animal studies [87, 88] Stage 1: First in human reported on their website but no clinical trials published Pending Stage 2b: At 3 centres currently undergoing trial. ClinicalTrials.gov Identifier: NCT04703829
Shurui Robot, Beijing Shurui Technology Co., Ltd** Figure 17 [106]	China, 2014	Not publicly available	Approvals: 2020 Passed special review procedure of Innovative Medical Devices of the State Food and Drug Administration No other information available Indications: Urology, gynaecology, general surgery, and thoracics	Set up: Operating trolley: Single port, 3 instruments and articulating endoscope. Differs from other single port as it has 1 arm per instrument feeding into 1 operating channel Main control trolley: Surgeon console with stereoscopic viewer Hand controller with digit grips similar to da Vinci Multi quadrant access External positioning arm remains motionless, increasing safety and reducing collision risks Ergonomics: Surgeon seated at main control trolley Instruments: Inserted on to separate arm that will then feed into common channel through the patient wall Vision: 3DHD		Stage 1 Supporting evidence: Stage 1: First domestic SP for gynaecology, RARP 2021 [89] partial nephrectomy 2021 [90], sigmoid colectomy in 2022 [91]. World first extra-peritoneal adrenalectomy 2021 [92]
Bitrack System, RobSurgical** [93] Figure 18	Spain, 2012 2014 1^st animal model operations	N/A currently not for sale Anticipated to be cheaper due to open platform	Approvals: No International Standards Organisation (ISO) 13,485 certification Intended indications: Urology, gynaecology, general surgery	Set up: Robot: 4 arms, extend from a column, generic trocars with general locations, smaller footprint. 2 passive joints avoids forces at the fulcrum point on the patient to reduce trauma, reducing clashing risk Surgeon console: Open console Ergonomics: Seated, adjustable with an arm rest Instruments: 8mm, single use, 7 DOF, monopolar and bipolar Vision: 3D Additional: Intended for hybrid laparoscopy and robotic procedures Open platform i.e. generic trocars, 3D screen, electrosurgical unit, and trocar location Developed AI systems: - Respiratory compensation system, - Intelligence Laparoscopic Navigation system	N/A	Stage 0 Supporting evidence: More than 30 in-vivo procedures performed
Carina™, Ronovo Surgical** Figure 19	China, 2021	N/A currently not for sale	Approvals: No	Set up: Modular system, 3–4 arms with a smaller footprint Vision: 3DHD	N/A	Stage 0 Supporting evidence: Animal and cadaver lab operations [94]
Enos™, Titan Medical Inc.* Figure 20	Canada, 2020 Rebranded from Single Port Orifice Robotic Technology -SPORT Expected human trials 2023 Expected product launch 2025 [95] Definitive agreement for collaboration with Medtronic confirmed for development of robotic technology [96]	N/A currently not for sale	Approvals: No IDE application data expected summer 2023	Set up: Open console, single port 25mm insertion tube with three articulating arms and camera Arms multiarticulated allowing four quadrant access, without external moving parts Instruments: Can be sterilised and reused, ten tip types that can be loaded and unloaded through insertion tube including monopolar hook, hunter and Maryland bipolar dissectors, needle driver, suture cut, tenaculum, fenestrated and laparoscopic clinch effectors Ergonomics: Seated, adjustable workstation Vision: 3DHD vision Portability: States smaller footprint, minimal cable management	Virtual reality: Integrated simulation software	Stage 0 Supporting evidence: Pre-clinical studies on pigs and cadaver [97] Website states > 80 pre-clinical lab procedures
Ottava, Johnson & Johnson**	USA Acquisition of Verb Surgical in 2019 [98] Announced in 2020	N/A currently not for sale	Approvals: N/A Possibly CE mark/FDA approval 2026 [98]	Set up: 6 arms to provide more control and flexibility in surgery which are integrated into the operating table. This zero-footprint design is to enable patient access, increase space in operating room and improve workflow – however there is scepticism regarding the six arms as this increases risk of clashes or entanglements Plans to combine with Auris’ Monarch robotic surgical platform to access and treat challenging anatomy in a minimally invasive way	N/A	Stage 0
MiroSurge, Institute of Robotics and Mechatronics at the German Aerospace Centre (DLR) Figure 21	Germany, 2017 Launched MIRO Innovation lab launched	N/A not for sale. Use in non-commercial/research purposes only Of note technological components of the MIRO robot were licensed to Medtronic in 2013 and utilised in HUGO™ RAS-System [99]	Approvals: No	Set up: MiroSurge is the entire telemanipulation modular system Each robotic arm is called MIRO Open console with 3D screen and glasses Hand controller and clutch foot pedal Ergonomics: Seated with arm rest Instruments: Currently use can support water jet for wound debridement, neurosurgery, US guided application, and robotic-assisted laparoscopy in development. Instruments are called MICA include forceps scissors, needle holder, palpation tip with a miniaturised sensor for haptic feedback). Sigma.7 provides artificial haptic feedback for system limitations e.g. joint limitation, collision avoidance Vision: 3D HD Storz Portability: Low weight of 10kg, accommodating 3kg payload, which can be mounted on side rails, walls, ceilings	N/A	Stage 0 – Note it will never go to in-human
Vicarious Surgical Inc** [100] Figure 22	USA, 2014	“Low cost of ownership”	Approvals: No, aiming for FDA clearance in 2024 Won the FDA Breakthrough Device Designation Indications: Targeting abdominal procedures particularly ventral hernia	Set up: Surgeon console, seated, arm rest, with cautery foot pedals and a 3D screen Single port incision through 1.2–1.8cm Ergonomics: Adjustable seating at the surgeon’s console Instruments: 2 working arms with 9 DOF, cantered pivoting inside the abdomen designed for the surgeon to work from any direction through any entry point Vision: 3DHD Portability: Patient and surgeon cart fit through a 34-inch (standard) doorway. Designed for easy setup, breakdown and storage	Virtual reality: Yes, with a VR headset	Stage 0 Supporting evidence: Stated performed well in cadaveric testing

Robotic system

Origin and use

Price

Regulatory approval and indications

Device description

Training pathways

IDEAL Framework Stage and evidence

da Vinci, Intuitive Surgical, Inc [16].*

Figure 3

USA, 1995 (Intuitive Surgical founded)

Launched 1st generation in 2000 after FDA approval for general laparoscopic surgery

Merged with ZEUS Robotic Surgical System 2003

1st operation 2000

Systems in use as of 31/12/22: 7,544 systems: 4,563 in the US, 1,388 in Europe, 1,234 in Asia and 359 in the R.O.W

Operations performed as of 31/12/22:

Estimated 1,875,000 during 2022, and over 10 million in total

Xi ~ $2 million with per procedure costs of roughly $2500 [17]

X stated ~ $1.2 million in SSI Mantra technology differentiator brochure

Approvals:

CE mark, FDA, Japanese Ministry of Health, Labour & Welfare (MHLW) 2012, China National Health Commissions 2018, UKCA Mark needed for GB market post June 2023

Indications multiport:

General surgery, urology, gynaecology, thoracic, paediatrics, plastics, head and neck specialties

Indications for SP:

Urology, TORS, and expanding

Set up: Master slave with surgeon, patient and vision cart. st generation da Vinci Surgical System

2nd generation da Vinci S

3rd generation da Vinci Si

4th generation Xi, X and single port (SP)

Xi: advanced instrumentation, vision, and features e.g. integrated table motion, setup automation allowing target anatomy and positioning guidance. Xi has a boom allowing multi-quadrant access

X: cost-conscious options with the same arm architecture as Xi ability for advanced analytics

SP: Flexible platform configuration, Single port 25mm cannula insertion holding three instruments and articulated 3D endoscope

Vision: 3DHD

Instruments: 8mm to 12mm, reusable (12 to 18 uses), has advanced energy and staplers

Additional information:

Firefly Fluorescence Imaging combined in the endoscope

Additional robots include Ion Endoluminal system for minimally invasive biopsies

Intuitive Hub System and My Intuitive app to record and track progress. Development of machine learning tools to help improve evaluation (launch stated hopefully 2023)

Intuitive offers grants for fellowships and research and development

Training:

Established modular training pathways TR100, TR200, TR300, TR400 and TR500 as in-hospital proctors. Includes training with patient cart assistance

Virtual reality:

Multiple validation studies of simulators [18] (dV-Trainer, da Vinci Skills Simulation from Mimic Technologies™ and da Vinci SimNow™), provide basic and procedure-specific simulation

Multiport—Stage 4

Single Port- Stage 3

Supporting evidence:

> 34,000 peer reviewed clinical journals

Multiple Studies, including RCTs, show long-term outcome data for multiport [19]

Single port in urology systematic review 2021 showed safety [20] and shorter hospital stay/less pain with otherwise comparable outcomes vs multiport in a systematic review and meta-analysis [21, 22]

da Vinci Application Programmer Interface via dVLogger recording device provide automated performance metrics which have been evaluated with concurrent [23]– [26], construct [27]– [29] and predictive [29]– [32] validity in some studies, with new research focusing on the application of AI

KANGDUO ROBOT® Surgical System (KD-SR-01), Suzhou Kangduo Robot Co., Ltd

Figure 4

China, 2013

Collaborating with University Harbin Institute for Technology

Countries in use:

China

1st operation: Pyeloplasty 7/8/2020

Currently 20 systems in use

Price:

$1–1.4 million

Approvals:

National Medicinal Products Administration (NMPA) of China Approval 2022

Approvals in Europe, Russia and Sri Lanka in progress

Indications: Urology, gynaecology, general surgery, thoracics

Set up:

Similarities to da Vinci:

Surgeon, patient and vision cart

Foot pedals have the same design as the da Vinci

Cross laser positioning system and boom like Xi

Filter tremor and motion scaling

Differences:

Only 3 arms and an open console

Instruments:

Fourteen 8mm instruments fenestrated grasper, double fenestrated grasper, tip-up double fenestrated grasper, Cadiere forceps, curved dissector, monopolar straight and curved scissors, large and small hook, Maryland bipolar forceps and large/small needle driver, fenestrated bipolar forceps, mini non-invasive round tip fenestrated

Reusable up to 10 times

Ergonomics: Seated, armrest

Vision:

3DHD with glasses, compatible with most 10mm 3D endoscopes

Additional:

ICG and 4KHD Fluorescence

Reconstruction and USS capability

5G remote surgery performed on a live animal successfully

Future models SR1500 and SR2000 in development and will include AI capabilities

Training:

Training centre in Beijing 1–2 days with animal operating

Virtual reality:

Co-designed with Simbionix, embedded within the surgeon console

Stage 3

Supporting evidence:

Pre-IDEAL (Stage 0)- RCT on porcine models [33]

Stage 1: First in human B/L pyeloplasty for horseshoe kidney [34]

Stage 2a:

Case reports on partial Nephrectomy [35, 36]

Prospective single-centre study for

pyeloplasty [37]

Stage 2b: Prospective single arm studies for RARP [38], partial adrenalectomy [39], pyeloplasty comparing to da Vinci Si, da Vinci outperformed in operative time and time per stitch [40]

Stage 3:

RARP- KangDuo vs da Vinci Si, comparable short-term functional and oncological outcomes [41]

2 centre blinded RCT

showing non-inferiority with da Vinci Si in RAPN for T1a renal tumours [42]

Senhance® Surgical Robotic System, Asensus Surgical Inc

Figure 5

USA, 2013–2016 developed and known as Telelap ALF-X. 2016

Launched with TransEnterix which became Asensus Surgical in 2021

1st Operation: Hysterectomy, Rome, Italy [43]

Use:

10,000 + operations worldwide

39 clinical sites US, Europe and Asia

6 global training centres

250 + active surgeon users

$1–1.2 million with per procedure costs ~ $1000 [17]

Benign hysterectomy: Procedure cost $1,393 da Vinci, $559 Senhance, laparoscopic $498 [44]

Approvals:

FDA and CE mark 2017

MHLW 2019

Further CE mark, FDA, MHLW approval for machine vision and augmented intelligence 2023

Indications:

Urology, General Surgery, Thoracic, Gynaecology, Paediatrics

Set up:

Open console from the surgeon’s cockpit

Modular system: Four manipulator arms (Japan and CE Markets only) are standalone units with digital fulcrum point; therefore, no docking to minimise trauma and increase workspace at the trocar

Hand controller as a laparoscopic instrument

Ergonomics: Seated in the surgeon’s cockpit, adjustable settings

Instruments:

Reusable, most are laparoscopic (non-articulated)

5mm bipolar grasper and needle driver are articulated

Hand/instrument movements are traditionally laparoscopic

Haptic feedback- an enhanced sense of force pressure and tension

3mm, 5mm and 10mm instruments. 70 + types, including advanced ultrasonic device

Vision:

3DHD with glasses

Eye tracking device, supplied by Tobii, is activated by the surgeon and moves the camera to the point of vision

Portability:

Easily portable due to bedside unit arms i.e. modular units

Additional:

Open platform architecture to be compatible with 3DHD and HD fluorescence systems, negating the need for software updates, as well as electrocautery units currently in the hospital, improving the economic feasibility

Machine vision/augmented intelligence- Intelligent Surgical Unit (ISU). Current capabilities include the automatic following of the tip of the instrument, smart zoom if you have a degreed scope keeping the image centred on relevant operative anatomy, and real-time, point-to-point and contour measurement allowing for example mesh sizing. In development: 3D mapping, instrument recognition, organ/critical structure detection

Training:

Whole team training 2 day dry and 1 day wet lab in Milan or Amsterdam. Scheduled case the week after for surgical proctor to attend the surgeon’s hospital, with a clinical specialist to support until fully independent

Stage 3

Supporting evidence:

Clinical evidence, 80 + reviewed publications, for 8 years, multicentre, multispecialty observational studies including from The TransEnterix European Patient Registry for Robotic-Assisted Laparoscopic Procedures in Urology, Abdominal, Thoracic, and Gynaecologic Surgery ("TRUST"). It is the largest multi-specialty robot-assisted laparoscopy registry. 2500 + patients enrolled

Safety and efficacy with low conversion and low complication rate from publications [45]

hinotori™ Surgical Robot System, Medicaroid Corporation**

Figure 6

Japan, 2013

Jointly established by Kawasaki Heavy Industries Ltd., and Sysmex Corporation

1st operation: December 2020

Not publicly available, states less than the equivalent 270 million yen of da Vinci Xi

Approvals:

Japanese Ministry of Health Labour & Welfare (MHLW) approval in August 2020

Indication and use in: Urology, General Surgery- gastrectomy 2022 [46], colorectal [47] and gynaecology [48]

Set up: “Operation unit” with 4 arms, 3 instruments and 1 endoscope holder on an “arm base” boom

“Surgical cockpit” has a 3D viewer, touch panel, hand control grips and foot unit similar to Intuitive’s design

Compact and safety design to minimise collisions and detect arm/port movement errors (Cubic-S), plus a vibration filtration

The pivot point position of the trocar on the patient’s body wall is monitored by Cubic-S. The software allows more workspace around the trocar as the arms do not dock to the trocar, therefore, there is a reduced risk of clashing with the patient or robotic arms

Robotic function can be enabled at the arm, operation cart panel or when the surgeon looks into the viewer

Ergonomics: Adjustable settings at the surgical cockpit

Vision: 3D HD

Instruments: Sterilisation with autoclave. Can be used up to 10 times

Portability: Compact, easily transferable between ORs

Additional:

Designed to be 5G compatible, anticipating telesurgery/remote operating, with an initial animal cadaver feasibility study showing safety in 2022 [49]

Training:

The whole healthcare team at Kobe University Hospital International Clinical Cancer Research Centre

Stage 2b

Supporting evidence:

Single centre prospective study 30 patients for RAPN [50] and a multicentre study of 30 patients for RARP [51]

Hugo™ RAS System, Medtronic*

Figure 7

USA, Launched 2021

Countries in use:

Australia, Belgium, Brazil, Canada, Chile, Denmark, Finland, France, Germany, India, Israel, Italy, Japan, Netherlands, Panama, Portugal, Spain, Sweden, Taiwan, United Kingdom

1st operation:

RARP, Chile 2021 [52]

Price:

Stated to be 20–25% cheaper than da Vinci Xi

Approvals:

CE mark 2021;

Health Canada License;

MHLW Japan;

Not FDA approved

Indications:

Urology, gynaecology, general surgery

Set up:

Modular, multi-quadrant platform

Surgeon console: Open console, pistol grip controllers, with motion scaling variability, compatibility with the Hugo task simulator. Pedals control the arms, energy supply (monopolar, bipolar), master clutch, camera control and arm switching

Arm cart: Three and four arm configurations, alternatively one arm can be used to assist in laparoscopic procedures

Hugo Tower: Touch screen monitor and central processing unit for the robotic system featuring KARL STORZ technologies, Valleylab™ FT10 energy platform and TouchSurgery™ Enterprise video management and analytics platform

Instruments:

Standard instruments and monopolar/bipolar. No advanced energy or stapling devices

Ergonomics:

Seated at surgeon console, adjustable

Vision: 3DHD with glasses, endoscope on any arm. Head tracking system which will disable control of the instruments if the surgeon is not looking at the monitor

Portability:

The modular system is easily portable

Additional:

Cloud-based surgical video capture option in Touch Surgery record procedures and gather data for viewing and analysis

Training: HUGO ASCEND Training Pathway. Modular training pathway with Technical Training (Medtronic Staff), Procedural Experience (by surgeons), Coaching (Surgeon to surgeon proctoring)

Other:

Onsite on demand support from engineers

Virtual reality:

Hugo™ task simulator, like da Vinci backpack simulators, attaches to the surgeon console

Stage 2b

Supporting evidence:

Stage 0: Report on left and right colectomy in cadavers Jan 2023 [53]

Stage 1: Multiple reports of first in-human cases for urology, gynaecology 2022 [52] and general surgery [54, 55]

Stage 2a: Case series in urology [56, 57]

Stage 2b: 112 patients undergoing RARP [58], 60 patients sacrocolpopexy [59]

MicroHand S Surgical Robot, Shandong WEGO Surgery Robot Co., Ltd. & ZCo Design Co., Ltd.**

Figure 8

China, 2013

Developed by Central South University and Tianjin University

1st operation in trial:

2014

Not publicly available

Approvals:

NMPA approval 2021 (in certain general surgery procedures) [60]

Set up:

“Doctor’s console” is open with an armrest, and finger grip hand controller

Patient console has 3 robotic arms

Vision: Vision console. 3DHD view

Ports: 10mm trocars for the robotic arms

Additional:

Incorporated 5G to allow remote operating, performing a radical cystectomy [61]

Stage 2b

Supporting evidence:

Single centre prospective centres:

- Lap vs robotic right hemi 22 patients, robotic outperformed [62]

- Versus da Vinci 45 patients undergoing sigmoid colectomy. Microhand shorter length of stay and improved hospital costs [63]

- Robotic TME vs. da Vinci Si, no difference found in patients’ genitourinary function; both outperformed lap [64]

- Other: sleeve gastrectomy (n = 7) [65] and a dry lab exercise showing construct validity of kinematic data on the MicroHand S robot

Revo-I, Meerecompany Inc

Figure 9

Republic of Korea, 2007

1^st human trials:

Cholecystectomies 2016 [66]

1^st operation (after approvals): RARP 2018

In use:

USA, Asia including Uzbekistan, Japan, Europe and R.O.W

Number of ops worldwide:

200 + by September 2021

Not publicly available but states a reduced price to be available in more countries

Approvals:

Ministry of Food and Drug Safety (MFDS) Approval 2018

Indications:

General Surgery, gynaecology, urology, ENT

Set up:

Similar to da Vinci Si

Master console, vision and patient cart

Surgeon console is closed

Ergonomics: Seated, adjustable

Instruments: 13 instrument types, short and long, 26 in total. Monopolar, bipolar, scissors, forceps, needle holders and clip appliers

Vision: 3DHD

Training:

Modular training pathway: online, dry/wet lab, procedural skills then robotic skill assessment

Supports with logistics, technical, marketing, open R&D, Revo Clinical Support Consultant

Virtual reality:

Revo-Sim with three modules- basic to advanced including procedural. 30 total tasks

Stage 2b

Supporting evidence:

Stage 1: First case in human case reports including prostatectomy and pancreatectomy [67]

Stage 2a/2b Prospective cohort study 17 patients undergoing RARP [68]

Prospective cohort study 15 patients undergoing cholecystectomy [66]

Stage 2b: Equivalent short term functional and oncological outcomes in propensity score analysis of 33 in each cohort Revo-I vs da Vinci Si [69]

Toumai® Laparoscopic Surgical Robot (MicroPort® Toumai®)

Shanghai MicroPort MedBot (Group) Co., Ltd. (MicroPort® MedBot®)** [70]

Figure 10

China, 2014

Design completed 2018

Use:

Over 30 Chinese centres

Not publicly available

Approvals:

National Medical Products Administration (NMPA), 2022 for Urology

Indications:

Urology, gynaecology, general surgery, thoracics [71]

Set up:

Similar to da Vinci Xi with 4 arms on a boom. Tremor filtration

Surgeon, vision and patient console

Vision: 3DHD

Additional:

Incorporated 5G for remote operating [71]. Stating world’s longest range performed (> 5000km) in June 2022

Toumai ® 2^nd generation awaiting NMPA approval

Toumai ® single arm commencing enrolment for clinical trials, completed 1^st in human

Other product including natural orifice and bronchoscopy developed

Training:

400 + senior surgeons trained, ~ 1500 training procedures complete

Stage 2b

Supporting evidence:

Clinical validation study of 1st generation, > 300 procedures in urology, gastrointestinal and gynaecology

Completed clinical trials for 2nd generation in gynaecology, thoracics and general surgery undergoing registration application phase

Versius®, Cambridge Medical Robotics (CMR) Surgical

Figure 11

UK, 2014

1^st Operation: 2019

Use:

Over 100 systems installed with over 5000 cases performed (November 2022)

Not publicly available

Flexible, bespoke contracts, including subscription/lease/capital purchase models

Approvals:

CE mark March 2019

Indications:

Adult

General surgery, gynaecology, urology, thoracics

Contraindications:

Paediatrics, Surgery relating to the circulatory or nervous system, radical hysterectomies with early-stage cervical cancer

Set up:

Open console, modular system

Hand controller likened to a split video game controller

Ergonomics:

Adjustable settings, armrest, seated or standing

Instruments: 6 fully articulated instruments

Vision: 3DHD with glasses

Portability: Footprint of each bedside unit arm: height 1425 mm/width 380 mm/depth 380 mm, height adjustable, neutral/sleep position is smaller than most average human height. Allows access to the patient

Additional:

“Soft” or “collaborative” robotics, doesn’t use a pully system like other robotic platforms, it has motors with torque sensors. This allows external force applied to the arm as a safety feature

Training:

Modular, whole team training pathway including e-learning (80% pass), dry and wet lab procedure run through

Preceptor present to check happy with the robot at the clinical site

Additional training offered

Virtual reality:

Versius Trainer

Stage 2b

Supporting evidence:

Stage 1/2a: First in human studies of 30 cases included cholecystectomy, appendicectomy, diagnostic laparoscopy, and gynaecological operations [72]

Stage 2b: Prospective observational study 32 participants in colorectal [73]

Other feasibility and pre-clinical studies are available on their website

MP1000 and SP1000 robots, Shenzen Edge Medical Robotics Co.**

Figure 12

Note: Unable to view the website, information has been taken from publications, web reports and draft material which may not accurately reflect the company or the robotic device

China, 2017

Operations in trial:

RARP 2021

Nephrectomy 2021

Hysterectomy 2021

Oophorectomy 2021

Distal gastrectomy 2022

Left hemicolectomy 2022

Pneumonectomy 2022

Not publicly available

Approvals:

Multiport system MP1000 approved in urological surgery by Chinese National Medical Products Administration (NMPA) in December 2022 [74]

Single Port (SP1000) under preclinical trials [74]

Likely NMPA approvals in 2023 for other specialties and SP1000

Indications:

General surgery urology, gynaecology and thoracics

Set up:

Multiport system MP1000

Standard master–slave set-up control with a surgeon, vision and patient cart with a 4-arm structure [75, 76]

Single port system SP1000

Same setup, 3 articulating arms with 7 DOF and an endoscope with 5 DOF. Same surgeon console for both robots

Photos suggest almost identical setup and controls to da Vinci Xi and da Vinci SP

In comparison to da Vinci SP with 4 DOF in endoscope, Edge Medical states 5 DOF

Instruments:

30 instruments, bipolar and monopolar

Developing Edge Robotic Ultrasonic Shears and Edge Robotic Stapler (stating this may not be successful) [60]

Vision: 3DHD

Additional:

Developing Edge Bronchoscope Robot

Stage 2a

Supporting evidence:

MP1000

Stage 2a (pending 2b): 1st clinical trial in 2021 [60]

Ongoing/finishing gynaecology clinical trial [60]

Initiated clinical trials and aimed to finish recruitment November 2022 in general surgery and thoracics

SP1000

Stage 0: Pre-clinical safety and feasibility in live porcine for nephrectomy [77] and taTME [78]

Stage 1/2a: SP1000 completed the operations of its first clinical trial in gynaecology [60]. A webpage report (May 2022) stated it has performed an in human ovarian cyst removal [79]

Dexter, Distalmotion®

Figure 13

Switzerland, 2012

Countries in use: Approval for use in European countries at this time

1^st operation: Rectopexy 2021, Gynaecology 2022, RARP 2022 [80]

Not publicly available

Approval: CE mark 2020

Indications: Urology, gynaecology, general surgery

Set up: Open console, modular system with two instrument arms and a robotic endoscope holder

On-demand laparoscopic and robotic platforms as the surgeon is sterile, allowing easy switching between the bedside and surgeon console. Use of traditional laparoscopic port positions

The hand controller is a pistol grip with finger and thumb paddles to open/close

Two foot pedals for clutch and camera

Instruments: Wristed, single-use, provided by Dexter. Five types including Johan, Maryland, monopolar hook, monopolar scissors, and needle holder. Open platform i.e., use of existing hospital laparoscopic tower and endoscope (if 3D)

Ergonomics: Fully adjustable to sit or stand

Vision: Open platform, 3D with glasses, imaging device agnostic which allows fluorescence imaging to be kept up-to-date as technology advances

Portability: Motorised, portable to other ORs

Training:

The Dexter Academy™. Modular training; didactic online off and on-site training including dry, wet (cadaver/live animal)

Dedicated clinical application specialist per site

Stage 2a

Supporting evidence:

Stage 1: nephrectomy [81], pelvic organ prolapse [82]

Stage 2a: Case series of 30 inguinal hernia repairs [83] and of the first 10 prostatectomies

Pending 2b: Recruitment for prospective clinical study ongoing ClinicalTrials.gov Identifier NCT05537727

avatera® system, avateramedical GmbH

Figure 14

Germany, 2011

1^st operation RARP, 2022

Countries in use:

Germany, Denmark, Greece, France, Hungary and others

Not publicly available

~ €1 million ($1.1) in 2019 [84]

Approval: CE mark 2019

Indications:

For use with patients who are eligible for laparoscopic surgical procedures according to the surgeon’s assessment and decision. It has been validated for urologic laparoscopic surgery such as prostatectomy, cystectomy, lymph node removal, ureter surgery and (partial) nephrectomy and gynaecological laparoscopic surgery such as hysterectomy, myomectomy and resection of endometriosis

Set up: 4-arm robotic unit, surgeon control unit and optional electrosurgery cart. Two joystick hand controllers with straps and finger clutches

Six-foot pedals for electrosurgery, camera and instrument switch

Eyepiece designed to leave ears and mouth uncovered

Instruments: Single use (except reusable endoscope), 5mm. Only bipolar available currently

Ergonomics: Built-in ergonomic chair, adjustable settings, stereoscopic eyepiece with headrest, ears “free” for communicating

Vision: 3D stereoscopic magnified view QXGA resolution (2048 × 1536px), overlay information on instruments, electrosurgery usage, statuses, and alarms

Portability: Easily moved by one person between rooms through standard doors

Additional highlights:

Next generation in development

The current system is very quiet within the OR due to no external fans

Modular training is available for the whole team with VR, Dry and wet (animal) lab

Proctors available for onsite training with performance evaluation

Virtual reality: In system simulation available

Stage 1

Supporting evidence:

Stage 0: Feasibility of robotic bilateral nephrectomy and radical cystectomy live porcine models [85, 86]

Pending 2b:

A current multicentre trial is running and registered on ISRCTN45854742

Mantra Surgical Robotic System, M/S. Sudhir, Srivastava Innovations (SSI) PVT. Ltd*

Figure 15

India, 2016

1^st Operation: July 2022

In use: India, Sri Lanka, Nepal, Bangladesh and Indonesia

Price: $625,000

Approvals:

CDSCO, India

Filing for CE mid 2023

Indications:

Cardiothoracic, Urology, General Surgery, Head and Neck, Gynaecology

Set up:

Open console, modular 3–5 arm system, foot pedals with arm switch, clutch, camera control and electrocautery

Vision cart has live streaming and recording capability for teletraining/telementoring

Ergonomics:

Seated, adjustable

Instruments:

30 + 9mm instruments (SSI MUDRA™) including monopolar, bipolar, and clip appliers. No advanced energy yet

Reusable with autoclave sterilisation

Developing other instruments

Vision: 3DHD, head tracking camera safety feature, articulating endoscope

Portability:

Modular with bedside units more easily portable, stowed dimensions are 610mm x 450mm x 1640mm

Additional:

Augmented reality intraoperative 3D holographic representation of patient’s anatomy with accurate MRI/CT scans

Training:

Currently only provided in India

Virtual reality:

SSI Mantra Virtual Reality Simulator

Stage 1

Supporting evidence:

Nil published currently, but in clinical use

MIRA Surgical System, Virtual Incision Corp.*

Figure 16

USA, 2006

1^st operation: Right hemicolectomy August 2021

N/A currently not for sale

Approvals:

The MIRA Surgical System is an Investigational Device and is not currently available for sale

Indications:

N/A

Minibot and camera:

Single port through ~ 2.5cm incision

MIRA features two robotic arms and an articulating high-definition camera. Motors are located inside the arms, with the goal of achieving triangulation at sufficient strength and dexterity, even for complex procedures like colon resection

The miniaturised design reduces the external footprint, potentially eliminating the need for dedicated OR space. It also enables multi-quadrant access with no external arm collisions

Surgeon console: Open console design

Hand controls have open-close paddles and sensors to detect the user, with a clutch function in the left hand and a camera function in the right

Foot pedals (clutch, camera, left hand bipolar, right hand monopolar)

Ergonomics:

Seated, open console maintaining peripheral vision of the operating room

Vision:

Full HD resolution in real-time on the main display

Portability:

MIRA’s miniaturised design is portable and aims to be easily set up in any operating room in a matter of minutes, eliminating the need for dedicated OR space and long turnover times. The minibot and camera are sterilised between cases like other instruments and stored on the shelf in a sterile tray. Just before the procedure, it is mounted on the patient table with no need for draping or docking

Haptic feedback: A haptic indicator detects when instruments are out of range

Additional:

Surgeon App (MIRA IQ) currently under development

Training:

Extensive training will be provided by the company

Virtual reality:

Simulator (MIRA Sim) currently under development

Stage 1

Supporting evidence:

Stage 0: Pre-clinical animal studies [87, 88]

Stage 1: First in human reported on their website but no clinical trials published

Pending Stage 2b: At 3 centres currently undergoing trial. ClinicalTrials.gov Identifier: NCT04703829

Shurui Robot, Beijing Shurui Technology Co., Ltd**

Figure 17 [106]

China, 2014

Not publicly available

Approvals:

2020 Passed special review procedure of Innovative Medical Devices of the State Food and Drug Administration

No other information available

Indications:

Urology, gynaecology, general surgery, and thoracics

Set up:

Operating trolley: Single port, 3 instruments and articulating endoscope. Differs from other single port as it has 1 arm per instrument feeding into 1 operating channel

Main control trolley: Surgeon console with stereoscopic viewer

Hand controller with digit grips similar to da Vinci

Multi quadrant access

External positioning arm remains motionless, increasing safety and reducing collision risks

Ergonomics:

Surgeon seated at main control trolley

Instruments:

Inserted on to separate arm that will then feed into common channel through the patient wall

Vision: 3DHD

Stage 1

Supporting evidence:

Stage 1: First domestic SP for gynaecology, RARP 2021 [89] partial nephrectomy 2021 [90], sigmoid colectomy in 2022 [91]. World first extra-peritoneal adrenalectomy 2021 [92]

Bitrack System, RobSurgical** [93]

Figure 18

Spain, 2012

2014 1^st animal model operations

N/A currently not for sale

Anticipated to be cheaper due to open platform

Approvals:

International Standards Organisation (ISO) 13,485 certification

Intended indications:

Urology, gynaecology, general surgery

Set up:

Robot: 4 arms, extend from a column, generic trocars with general locations, smaller footprint. 2 passive joints avoids forces at the fulcrum point on the patient to reduce trauma, reducing clashing risk

Surgeon console: Open console

Ergonomics: Seated, adjustable with an arm rest

Instruments:

8mm, single use, 7 DOF, monopolar and bipolar

Vision: 3D

Additional:

Intended for hybrid laparoscopy and robotic procedures

Open platform i.e. generic trocars, 3D screen, electrosurgical unit, and trocar location

Developed AI systems:

- Respiratory compensation system,

- Intelligence Laparoscopic Navigation system

N/A

Stage 0

Supporting evidence:

More than 30 in-vivo procedures performed

Carina™, Ronovo Surgical**

Figure 19

China, 2021

N/A currently not for sale

Approvals:

Set up:

Modular system, 3–4 arms with a smaller footprint

Vision: 3DHD

N/A

Stage 0

Supporting evidence:

Animal and cadaver lab operations [94]

Enos™, Titan Medical Inc.*

Figure 20

Canada, 2020

Rebranded from Single Port Orifice Robotic Technology -SPORT

Expected human trials 2023

Expected product launch 2025 [95]

Definitive agreement for collaboration with Medtronic confirmed for development of robotic technology [96]

N/A currently not for sale

Approvals:

IDE application data expected summer 2023

Set up:

Open console, single port 25mm insertion tube with three articulating arms and camera

Arms multiarticulated allowing four quadrant access, without external moving parts

Instruments: Can be sterilised and reused, ten tip types that can be loaded and unloaded through insertion tube including monopolar hook, hunter and Maryland bipolar dissectors, needle driver, suture cut, tenaculum, fenestrated and laparoscopic clinch effectors

Ergonomics: Seated, adjustable workstation

Vision: 3DHD vision

Portability: States smaller footprint, minimal cable management

Virtual reality: Integrated simulation software

Stage 0

Supporting evidence:

Pre-clinical studies on pigs and cadaver [97]

Website states > 80 pre-clinical lab procedures

Ottava, Johnson & Johnson**

USA

Acquisition of Verb Surgical in 2019 [98]

Announced in 2020

N/A currently not for sale

Approvals:

N/A

Possibly CE mark/FDA approval 2026 [98]

Set up:

6 arms to provide more control and flexibility in surgery which are integrated into the operating table. This zero-footprint design is to enable patient access, increase space in operating room and improve workflow – however there is scepticism regarding the six arms as this increases risk of clashes or entanglements

Plans to combine with Auris’ Monarch robotic surgical platform to access and treat challenging anatomy in a

minimally invasive way

N/A

Stage 0

MiroSurge, Institute of Robotics and Mechatronics at the German Aerospace Centre (DLR)

Figure 21

Germany, 2017

Launched MIRO Innovation lab launched

N/A not for sale. Use in non-commercial/research purposes only

Of note technological components of the MIRO robot were licensed to Medtronic in 2013 and utilised in HUGO™ RAS-System [99]

Approvals: No

Set up: MiroSurge is the entire telemanipulation modular system

Each robotic arm is called MIRO

Open console with 3D screen and glasses

Hand controller and clutch foot pedal

Ergonomics: Seated with arm rest

Instruments: Currently use can support water jet for wound debridement, neurosurgery, US guided application, and robotic-assisted laparoscopy in development. Instruments are called MICA include forceps scissors, needle holder, palpation tip with a miniaturised sensor for haptic feedback). Sigma.7 provides artificial haptic feedback for system limitations e.g. joint limitation, collision avoidance

Vision: 3D HD Storz

Portability: Low weight of 10kg, accommodating 3kg payload, which can be mounted on side rails, walls, ceilings

N/A

Stage 0 – Note it will never go to in-human

Vicarious Surgical Inc** [100]

Figure 22

USA, 2014

“Low cost of ownership”

Approvals:

No, aiming for FDA clearance in 2024

Won the FDA Breakthrough Device Designation

Indications:

Targeting abdominal procedures particularly ventral hernia

Set up: Surgeon console, seated, arm rest, with cautery foot pedals and a 3D screen

Single port incision through 1.2–1.8cm

Ergonomics: Adjustable seating at the surgeon’s console

Instruments:

2 working arms with 9 DOF, cantered pivoting inside the abdomen designed for the surgeon to work from any direction through any entry point

Vision: 3DHD

Portability:

Patient and surgeon cart fit through a 34-inch (standard) doorway. Designed for easy setup, breakdown and storage

Virtual reality:

Yes, with a VR headset

Stage 0

Supporting evidence:

Stated performed well in cadaveric testing

Companies who underwent virtual interviews have no asterisk

*Companies who replied via email

**Companies who did not respond and information was gathered purely from the public domain