FDA-cleared AI gastroenterology-urology devices
The FDA's AI-enabled device list has 27 devices whose lead review panel is Gastroenterology-Urology, 1.7% of all 1,614 listed devices. They come from 18 companies. The first decision was on May 25, 2018 and the most recent on June 4, 2026.
27AI devices
14Companies
2018First decision
2026-06-04Latest decision
Guides for gastroenterology-urology
Trend: devices per year
2018202120222023202420252026
Top companies
Most common product codes
All 27 devices, newest first
- Instrument Exit Point on Touch Surgery AideCovidien, LLC · Gastroenterology-Urology
- GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US)Cosmo Artificial Intelligence - Ai, Ltd. · Gastroenterology-Urology
- MAGENTIQ-COLO (ME-APDS)Magentiq Eye, Ltd. · Gastroenterology-Urology
- Deep Capsule® (Deep Capsule US)Digestaid - Artificial Intelligence Development SA · Gastroenterology-Urology
- SKOUT systemIterative Health · Gastroenterology-Urology
- Gastric AlimetryAlimetry , Ltd. · Gastroenterology-Urology
- MAGENTIQ-COLO (ME-APDS)Magentiq Eye, Ltd. · Gastroenterology-Urology
- CADDIEOdin Medical Limited · Gastroenterology-Urology
- Maestro System (REF100)Moon Surgical · Gastroenterology-Urology
- HyperSnap Surgical System (HSS)Hypervision Surgical · Gastroenterology-Urology
- SKOUT systemIterative Health · Gastroenterology-Urology
- MAGENTIQ-COLO (ME-APDS)Magentiq Eye LTD · Gastroenterology-Urology
- GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US); GI Genius Module 300 (GGM300-US); ColonPRO 4.0 (CPRO40S-US)Cosmo Artificial Intelligence - AI Ltd · Gastroenterology-Urology
- CADDIEOdin Medical Limited · Gastroenterology-Urology
- SKOUT® systemIterative Scopes, Inc. · Gastroenterology-Urology
- SKOUT® systemIterative Scopes, Inc. · Gastroenterology-Urology
- GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US)Cosmo Artificial Intelligence - AI Ltd · Gastroenterology-Urology
- EW10-EC02 Endoscopy Support ProgramFUJIFILM Corporation · Gastroenterology-Urology
- NaviCam ProScanAnkon Technologies co., ltd · Gastroenterology-Urology
- ME-APDS; MAGENTIQ-COLOMagentiq Eye LTD · Gastroenterology-Urology
- GI Genius System 100 and GI Genius System 200Cosmo Artificial Intelligence - AI Ltd · Gastroenterology-Urology
- SKOUT® systemIterative Scopes Inc. · Gastroenterology-Urology
- SKOUT SoftwareIterative Scopes Inc. · Gastroenterology-Urology
- EndoScreenerChengdu Wision Medical Device Co., LTD. · Gastroenterology-Urology
- GI GeniusCosmo Artificial Intelligence - AI Ltd · Gastroenterology-Urology
- GI GeniusCosmo Artificial Intelligence - AI, LTD · Gastroenterology-Urology
- TransEnterix Senhance Surgical SystemTransEnterix, Inc. · Gastroenterology-Urology
Frequently asked questions
How many FDA-cleared AI gastroenterology-urology devices are there?
As of the FDA list updated through June 29, 2026, 27 AI-enabled devices have Gastroenterology-Urology as their lead review panel (1.7% of the list).
Which companies have the most AI gastroenterology-urology devices?
Cosmo Artificial Intelligence - AI Ltd (4), Magentiq Eye, Ltd. (2), Iterative Health (2) have the most AI-enabled gastroenterology-urology devices on the FDA list.
Which year had the most AI gastroenterology-urology authorizations?
2025 had the most, with 8 devices.
Which FDA pathways are used for AI gastroenterology-urology devices?
510(k): 25; De Novo: 2.
What was the most recent AI gastroenterology-urology device on the list?
Instrument Exit Point on Touch Surgery Aide from Covidien, LLC (K253984), with a decision dated June 4, 2026.