Table 2.
Regulatory approvals and available information of the robotic platforms.
| Clinically Adopted Platforms | ||||
|---|---|---|---|---|
| Company | Product Name | Country | Regulatory Approvals | Marketing Information (n. Procedures/Platform) |
| Medtronic | Hugo™ RAS | US | FDA: ongoing CE-mark: general surgery; urology; gynecology Australian TGA: urology; gynecology Health Canada: general surgery MHLW PMDA Japan: urology; gynecology |
NR |
| Cambridge Medical Robotics | Versius® | England | CE-mark: general surgery; urology; gynecology; thoracic surgery Australian TGA: general surgery; urology; gynecology Anvisa Brazil: general surgery; urology; gynecology Other countries: India; Pakistan; Egypt |
10,000 procedures performed (March 2023) [114] >100 installed platforms (November 2022) [115] |
| Intuitive Surgical | Da Vinci SP® | US | FDA: urology; transoral procedures MHLW PMDA Japan: urology; gynecology; general surgery; thoracic surgery; transoral MFDS Korea: urology; general surgery; gynecology; thoracic surgery; transoral NMPA China: yes, not specified |
121 installed platform (December 2022) [116] A’design award winner 2019 |
| Medrobotics Corp. | Flex® Robotic System | US | FDA: transoral; colorectal; general surgery; gynecology; thoracic surgery CE-mark: colorectal Australian TGA: colorectal |
Bankrupt of the producing company |
| Asensus (formerly TransEnterix) |
Senhance® ALF-X | US | FDA: general surgery; gynecology. Pediatric surgery expected in 2023 CE-mark: general surgery; gynecology; pediatric surgery MHLW PMDA Japan: urology; gynecology; general surgery; thoracic surgery Roszdravnadzor—Russia: yes, not specified Taiwan: yes, not specified |
>10,000 procedures performed (February 2023) >49 installed platforms between 2016 and 2022 [117] |
| Meerecompany Inc. | Revo-i™ | South Korea | MFDS Korea: urology; gynecology; general surgery | NR |
| Wego | Micro Hand S | China | NMPA China: general surgery | Reddot award winner 2022 |
| Platforms under Clinical Investigation | ||||
| Company | Product Name | Country | Regulatory Approvals | Marketing Information |
| Medicaroid | Hinotori™ | Japan | MHLW PMDA Japan: urology; gastrointestinal; gynecology | 840 procedures (December 2022) 28 installed platforms (September 2022) [118] |
| Avatera Medical | Avatera | Germany | CE-mark: urology; gynecology | Fist clinical procedure in May 2022 [119] |
| Distalmotion | Dexter | Switzerland | CE-mark: general surgery; gynecology | 4 installed platforms [120] iF design award 2020 |
| Moon Surgical | Maestro | US | FDA: laparoscopic procedures CE-mark: laparoscopic procedures |
30 procedures performed [121] |
| Virtual Incision | MIRA | US | FDA: completed IDE for bowel resections. De novo classification pathway ongoing | NR |
| Titan Medical Inc. | ENOS™ (formerly SPORT) | Canada | FDA: planned in 2023 CE-mark: planned in 2023/24 |
NR |
| SS Innovation | Mantra | India | FDA: planned in 2023 CE-mark: planned in 2023 Other countries: India |
5 installed platforms 100 procedures performed [122] |
| Rob Surgical Systems S | Bitrack System | Spain | NR | First clinical trial ongoing [123] |
US: United States; FDA: food and drug administration; CE: Conformité Europeenne; TGA: Therapeutic Goods Administration; MHLW PMDA: Ministry of Health, Labour and Welfare Pharmaceuticals and Medical Devices Agency; NR: not reported; MFDS: Ministry of Food and Drug Safety; NMPA: National Medical Products Administration; IDE: Investigational Device Exemption.