The 10 AI algorithms FDA-cleared for gastroenterology

As of May 13, the FDA has cleared 882 AI/ML-enabled medical devices, including 10 gastroenterology products. 

The cleared devices have met the FDA’s applicable premarket requirements, including a review of the devices’ safety and effectiveness. 

Note: The FDA's list is not meant to be an exhaustive or comprehensive resource of medical devices that incorporate AI/ML. Rather, it is a list of medical devices that incorporate AI/ML across medical disciplines.

The 10 gastroenterology AI/ML-enabled medical devices cleared by the FDA: 

Cosmo Artificial Intelligence's GI Genius Module 100, GI Genius Module 200 and ColonPRO 4.0 

FujiFilm's EW10-EC02 Endoscopy Support Program

Magentiq Eye's ME-APDS and MAGENTIQ-COLO

Cosmo Artificial Intelligence's GI Genius System 100 and GI Genius System 200

Iterative Scopes' Skout System 

Alio's Alio 

Iterative Scopes' Skout Software 

Chengdu Wision Medical Devices' EndoScreener 

Cosmo Artificial Intelligence's GI Genius 

ImpediMed Limited's SOZO

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