Table 1.
List of AI-associated/associable equipped medical devices approved by the US FDA specifically for oncology-related fields.
| N° | Month of approval | Name of the device | Description of the device and its role | Specific area of interest |
|---|---|---|---|---|
| 1 | February 2015 | ER APP, Breast Cancer (Visiopharm A/S) | Determination of oestrogen receptor positivity and negativity in breast cancer | Pathology |
| 2 | February 2015 | PR APP, Breast Cancer (Visiopharm A/S) | Determination of progesterone receptor positivity and negativity in breast cancer | Pathology |
| 3 | August 2015 | Kaiku Health (Kaiku Oy) | Outcome monitoring and symptom tracking for cancer patients | Clinical Oncology |
| 4 | November 2015 | ClearRead CT (Riverain Technologies LLC.) | Assistance in review of multi-slice computed tomography exams of the chest and detection of potential nodules that radiologist should review | Cancer Radiology |
| 5 | December 2015 | Transpara (ScreenPoint Medical BV) | Reading aid for physicians interpreting screening mammograms to identify regions suspicious for breast cancer | Cancer Radiology |
| 6 | June 2016 | SmartTarget (SmartTarget Ltd.) | Image-guided interventional and diagnostic procedures involving the prostate gland | Cancer Radiology |
| 7 | September 2016 | Eclipse Treatment Planning System V15.6 (arian Medical Systems Inc.) | Radiotherapy treatment planning for patients with malignant or benign diseases | Radiation Oncology |
| 8 | August 2016 | LungQ (Thirona Corp.) | Support in diagnosis and documentation of pulmonary tissues images (eg, abnormalities) from CT thoracic datasets | Cancer Radiology |
| 9 | March 2017 | ColonFlag (Medial EarlySign Inc.) | High risk colorectal cancer detection support for pre-symptomatic patients | Gastroenterology |
| 10 | May 2017 | AmCAD-US (AmCad BioMed Corporation) | A software to visualise and quantify ultrasound image data with backscattered signals. | Cancer Radiology |
| 11 | June 2017 | C the Signs (C the Signs Ltd.) | Assessment of symptoms to support cancer diagnosis | Clinical Oncology |
| 12 | July 2017 | QuantX (Quantitative Insights) | An AI-equipped diagnosis system to aid in accurate diagnosis of breast cancer. | Cancer Radiology |
| 13 | December 2017 | Veye Chest (Aidence BV) | Pulmonary nodule detection support from CT scans | Cancer Radiology |
| 14 | January 2018 | Arterys Oncology DL (Arterys) | An AI-based, cloud-based medical imaging software that automatically measures and tracks lesions and nodules in MRI and CT. | Cancer Radiology |
| 15 | January 2018 | GI Genius (Medtronic Inc. (parent company: Medtronic plc.)) | Colorectal cancer detection support | Gastroenterology |
| 16 | January 2018 | QVCAD (QView Medical Inc.) | Aid to detect mammography-occult lesions in regions not known to have suspicious findings | Cancer Radiology |
| 17 | February 2018 | DLCExpert (Mirada Medical Ltd.) | Contouring assistance for radiation therapy from CT scans | Radiation Oncology |
| 18 | May 2018 | HealthMammo (Zebra Medical Vision Inc.) | Mammograms processed and analysed for suspected breast cancer lesions | Cancer Radiology |
| 19 | July 2018 | Arterys Oncology DL (Arterys Inc.) | Support of oncological workflow by helping user confirm absence or presence of lesions; application supports anatomical datasets, such as CT or MR | Cancer Radiology |
| 20 | October 2018 | Hot Spot APP (Visiopharm A/S) | Hotspot scoring method for various cancer applications | Pathology |
| 21 | October 2018 | Invasive Tumour Detection APP (Visiopharm A/S) | Cytokeratin and p63 marker assessment for invasive and non-invasive tumour distinguishment | Pathology |
| 22 | October 2018 | AmCAD-UT (AmCad BioMed Corporation) | Assistance in analysis of thyroid ultrasound images | Cancer Radiology |
| 23 | October 2018 | Mia -Mammography Intelligent Assessment (KheironMedical Technologies Ltd.) | Breast cancer detection support from mammograms | Cancer Radiology |
| 24 | October 2018 | Arterys MICA (Arterys) | An AI-based platform for analysing medical images such as MRI and CT. | Cancer Radiology |
| 25 | November 2018 | SubtlePET (Subtle Medical) | An AI-powered technology that enables centers to deliver a faster and safer patient scanning experience, while enhancing exam throughput and provider profitability. | Cancer Radiology |
| 26 | February 2019 | DERM (Skin Analytics Ltd.) | Skin cancer diagnosis support | Clinical Oncology |
| 27 | February 2019 | ART-Plan.annotate (heraPanacea SAS) | Contouring of tumour and surrounding organs for radiotherapy | Radiation Oncology |
| 28 | March 2019 | cmTriage (CureMetrix) | An AI-based triage software for mammography. | Cancer Radiology |
| 29 | April 2019 | Deep Learning Image Reconstruction (GE Medical Systems) | A deep-learning-based CT image reconstruction technology. | Cancer Radiology |
| 30 | April 2019 | Auto Lung Nodule Detection (Samsung Electronics Co. Ltd. (parent company: Samsung Group) | Lung nodule detection for diagnostic support from X-ray images | Cancer Radiology |
| 31 | May 2019 | JPC-01K (JLK Inspection Inc.) | Prostate cancer detection for diagnostic support from MRI images | Cancer Radiology |
| 32 | May 2019 | syngo.Breast Care (Siemens Healthcare GmbH (parent company: Siemens AG)) | Reading and reporting for diagnostic support from mammograms | Cancer Radiology |
| 33 | June 2019 | Aquilion ONE (TSX-305A/6) V8.9 with AiCE (Canon MedicalSystems Corporation) | A device to acquire and display cross-sectional volumes of the whole body, including the head, with the capability of imaging whole organs in a single rotation. | Cancer Radiology |
| 34 | July 2019 | ProFound AI for 2D Mammography (iCAD Inc.) | Breast cancer detection assistance and workflow solution from 2D mammograms | Cancer Radiology |
| 35 | July 2019 | ProFound AI for Digital Breast Tomosynthesis (iCAD Inc.) | Computer-assisted detection and diagnosis (CAD) software device intended to be used while reading digital breast tomosynthesis (DBT) exams | Cancer Radiology |
| 36 | July 2019 | RayCare 2.3 (RaySearch Laboratories) | An oncology information system used to support workflows, scheduling and clinical information management for oncology care and follow-up. | Cancer Radiology |
| 37 | August 2019 | Ethos Radiotherapy Treatment (Varian Medical Systems Inc.) | Managing and monitoring radiation therapy treatment plans and sessions | Radiation Oncology |
| 38 | September 2019 | AVEC (Automated Visual Evaluation of the Cervix) (MobileODT Ltd.) | Cervical cancer screening support for diagnostic support | Gynecology |
| 39 | September 2019 | Breast-SlimView (Hera-MI SAS) | Breast cancer detection for diagnostic support from mammograms | Cancer Radiology |
| 40 | September 2019 | Vara (Merantix Healthcare GmbH) | Breast cancer screening support and triaging from mammograms | Cancer Radiology |
| 41 | October 2019 | ProFound AI Software V2.1 (iCAD) | A CAD software device intended to be used concurrently by interpreting physicians while reading DBT | Cancer Radiology |
| 42 | October 2019 | DeepDx-Prostate Connect (Deep Bio Inc.) | Recognition of acinar adenocarcinoma of the prostate | Pathology |
| 43 | November 2019 | Paige Prostate (Paige Inc.) | Cancer detection in prostate needle biopsies | Pathology |
| 44 | November 2019 | Paige Insight (Paige Inc.) | Digital pathology viewer for diagnostic support | Pathology |
| 45 | December 2019 | Transpara (ScreenPoint Medical) | A device for use as a concurrent reading aid for physicians interpreting screening mammograms from compatible FFDM systems to identify regions suspicious for breast cancer and assess their likelihood of malignancy. | Cancer Radiology |
| 46 | December 2019 | QyScore software (Qynapse SAS) | Automatic labelling, visualisation and volumetric quantification of segmentable brain structures and lesions from MR images | Cancer Radiology |
| 47 | December 2019 | Discovery AI (Pentax Medical GmbH (parent company: Pentax Corporation)) | Polyp detection support during a colorectal examination | Gastroenterology |
| 48 | December 2019 | RayStation (RaySearch Laboratories AB) | Treatment planning and analysis of radiation therapy | Radiation Oncology |
| 49 | December 2019 | RayCare 2.3 (RaySearch Laboratories AB) | Support of workflows, scheduling and clinical information management for oncology care and follow-up | Clinical Oncology |
| 50 | January 2020 | JBD-01K (JLK Inspection Inc.) | Breast cancer detection for diagnostic support from mammograms | Cancer Radiology |
| 51 | January 2020 | AI-Pathway Companion Prostate Cancer (Siemens Healthcare GmbH (parent company: Siemens AG) | Prostate cancer detection for diagnostic support | Clinical Oncology |
| 52 | January 2020 | MRCAT Brain (Philips Medical Systems MR Finland (parent company: Philips NV)) | Radiation therapy planning through automated image segmentation for brain tumour patients | Radiation Oncology |
| 53 | February 2020 | InferRead CT Lung (Beijing Infervision Technology Co. Ltd.) | Lung cancer screening and management tool from CT scans | Cancer Radiology |
| 54 | February 2020 | b-box (b-rayZ GmbH) | Assessment of mammography image quality and breast density from mammograms | Cancer Radiology |
| 55 | February 2020 | Metastasis Detection App (Visiopharm A/S) | Metastasis detection in lymph nodes for colorectal and breast adenocarcinoma | Pathology |
| 56 | February 2020 | Galen Prostate (Ibex Medical Analytics Ltd) | Identification of suspected cancer on prostate core needle biopsies | Pathology |
| 57 | February 2020 | densitasAI (Densitas Inc.) | Breast density assessment support from mammograms | Cancer Radiology |
| 58 | March 2020 | Broncholab (Fluidda Inc) | Support in diagnosis and documentation of pulmonary tissue images(eg, abnormalities) from CT thoracic datasets | Cancer Radiology |
| 59 | March 2020 | Syngo.CT Lung CAD (Siemens Medical Solutions Inc. (parent company: Siemens AG)) | Assistance in detection of solid pulmonary nodules during review of multi-detector computed tomography examinations of the chest | Cancer Radiology |
| 60 | March 2020 | MammoScreen (Therapixel SA) | Help to identify findings on screening FFDM acquired with compatible mammography systems and assess level of suspicion | Cancer Radiology |
| 61 | March 2020 | CAD EYE (FUJIFILM Europe GmbH) | Colonic polyps detection and characterisation support during a colonoscopy | Gastroenterology |
| 62 | May 2020 | NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (AnX Robotica, Inc.) | A magnetically maneuvered capsule endoscopy system consists of an ingestible capsule and magnetic controller and is used for visualisation of the stomach and duodenum. The magnetic controller is used outside of the patient and is magnetically coupled with the capsule to control its location and viewing direction. | Gastroenterology |
| 63 | June 2020 | Cobas® EZH2 Mutation Test (Roche Molecular System, Inc.) | The test is intended for the identification of follicular lymphoma patients with an EZH2 mutation for treatment with TAZVERIK (tazemetostat); coupled with the cobas z 480 analyzer. | Pathology |
| 64 | July 2020 | Her2 dual ish dna probe cocktail | It is intended to determineHER2 gene amplification status by enumeration of the ratio of the HER2 gene to Chromosome 17 by light microscopy. | Pathology |
| 65 | October 2020 | Cintec plus cytology (Ventana Medical Systems, Inc.) | Qualitative immunocytochemical assay for the simultaneous detection of the p16INK4a and Ki-67 proteins in cervical specimens, intended for the diagnosis of cervical cancer. | Pathology |
| 66 | November 2020 | Genius AI Detection (Hologic, Inc.) | Software device intended to identify potential abnormalities in breast tomosynthesis images | Cancer Radiology |
| 67 | November 2020 | FoundationOne Liquid CDx (Foundation Medicine, Inc.) | It is a qualitative NGS-based test interrogating 311 genes. It utilises circulating cell-free DNA (cfDNA) isolated from plasma of cancer patients, and is intended to be used as a companion diagnostic to identify patients who may benefit from treatment with targeted therapies (targets identified with NGS) | Pathology |
| 68 | January 2021 | Visage Breast Density (Visage Imaging) | The software application is intended for use with compatible full-field digital mammography to aid radiologists in the assessment of breast tissue composition | Cancer Radiology |
| 69 | January 2021 | Imagio Breast Imaging System (Seno Medical Instruments, Inc.) | Allows an improved classification of breast masses compared to ultrasound alone; includes an AI-based software. | Cancer Radiology |
| 70 | April 2021 | VENTANA MMR RxDx Panel (Ventana Medical Systems, Inc.) | CDx for identifying patients with endometrial cancer with dMMR status who may benefit from treatment with Jemperli (dostarlimab-gxly). | Pathology |
| 71 | April 2021 | GI Genius (Cosmo Artificial Intelligence—AI, LTD) | It is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as polyps and adenomas) in real time during standard white-light endoscopy. | Gastroenterology |
Summary of the different oncology-related medical areas of all AI-associated devices approved by FDA: 39 cancer radiology (54.9%); 14 pathology (19.7%); 6 radiation oncology (8.5%); 6 gastroenterology (8.5%); 5 clinical oncology (7.0%), gynecology 1 (1.4%).
Summary of the different tumour types investigated by the presented devices: 24 general cancers (33.8%); 22 breast cancer (31.0%); 6 lung cancer (8.5%); 6 prostate cancer (8.5%); 5 colorectal cancer (7.0%); 2 brain tumours (2.8%); 6 others (6 types): 1.4% each.
AI artificial intelligence, US FDA United States Food and Drug Administration, CT computed tomography, MRI magnetic resonance imaging, ECG electrocardiogram, CAD computer-aided detection/diagnosis, DBT digital breast tomosynthesis, FFDM full-field digital mammography.