Endoscopy AI medical devices

A neutral, evidence-based catalogue of endoscopy AI medical devices. No manufacturer pricing, no buy links — just regulatory facts and clinical capability summaries.

Endoscopy

CADDIE

Olympus Corporation (Odin Medical Ltd.)

CEFDA

Real-time cloud-based computer-aided detection (CADe) of suspected colorectal polyps during white-light colonoscopy, delivering visual bounding-box alerts to the endoscopist without altering the endoscope hardware.

Endoscopy

MAGENTIQ-COLO (ME-APDS)

Magentiq Eye, Ltd.

CEFDA

Real-time computer-aided detection (CADe) software for colonoscopy. The system takes the video output of the endoscopy processor, runs a deep neural network on each frame and draws a bounding box on a separate screen around regions whose appearance is consistent with a mucosal abnormality such as a polyp. It is a detection aid only: it does not characterise lesions, does not diagnose, and does not replace histopathology. The FDA clearance covers screening and surveillance colonoscopy in standard white light. Since the 2025 clearance the box disappears while a snare or forceps is in view.

Endoscopy

SKOUT system

Iterative Health (formerly Iterative Scopes)

FDA

Real-time computer-aided detection (CADe) software for colonoscopy. SKOUT analyses the live white-light video feed during a standard colonoscopy and draws a blue rectangular outline around regions the model scores as a suspected colorectal polyp; when no candidate is present, no box appears, and detection pauses automatically when endoscopic instruments are detected in the field so the overlay does not obstruct a biopsy or resection. It is a concurrent second observer: detection and localisation only, with no histology characterisation and no autonomy — the gastroenterologist reviews every flagged region and decides what to inspect, resect and send to pathology. The system is indicated for white-light colonoscopy only.

Endoscopy

Deep Capsule (Deep Capsule US)

DigestAID - Artificial Intelligence Development, S.A.

FDA

Deep-learning reading aid for pre-recorded small-bowel capsule-endoscopy video. The software analyses the full study, selects frames suspected of containing a small-bowel lesion and presents them as a thumbnail gallery alongside the video, so that the reviewing clinician can work through a curated set rather than the whole recording. The US-cleared indication is narrow and specific: an AI-assisted reading tool to reduce the time taken to review capsule-endoscopy images in adults examined for suspected small-bowel bleeding. The cleared software detects lesions without differentiating them and is not intended to characterise lesions; the lesion-type and bleeding-risk outputs described in the manufacturer's research papers and marketing are not part of the US clearance. The clinician remains responsible for reviewing the entire video.

Endoscopy

GI Genius

Cosmo Intelligent Medical Devices (distributed by Medtronic)

CEFDA

Real-time computer-aided detection (CADe) software for colonoscopy. GI Genius processes the live white-light video feed during a standard colonoscopy and overlays a green bounding box on regions the model scores as suspicious for a colonic mucosal lesion — a polyp or adenoma — as the endoscope is withdrawn. It is a concurrent "second observer": detection and localisation only, not characterisation (it does not predict whether a lesion is neoplastic) and not autonomous. The endoscopist decides what to inspect, resect and send to pathology. The AI software is branded ColonPRO; Cosmo develops and manufactures the system and Medtronic is its exclusive worldwide distributor.

Endoscopy

CADU

Olympus Corporation (Odin Medical Ltd.)

Editorial summaryEndoscopy

SMARTIBD

Olympus Corporation (Odin Medical Ltd.)

Editorial summary

Other specialties