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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