De Novo · Gastroenterology-Urology

GI Genius

by Cosmo Artificial Intelligence - AI, LTD

GI Genius is an AI-enabled medical device from Cosmo Artificial Intelligence - AI, LTD that the U.S. FDA granted through De Novo DEN200055 on April 9, 2021. Its lead review panel is Gastroenterology-Urology and its primary product code is QNP (Gastrointesinal Lesion Software Detection System).

See also all FDA AI clearances in 2021, top gastroenterology-urology AI devices.

Key facts

Submission numberDEN200055
PathwayDe Novo
Date of final decision
Company (FDA list)Cosmo Artificial Intelligence - AI, LTD
Lead review panelGastroenterology-Urology
Primary product codeQNP — Gastrointesinal Lesion Software Detection System
Applicant (openFDA)Cosmo Artificial Intelligence - Ai, Ltd.
Applicant locationDublin, IE
Device classClass 2
Regulation number21 CFR 876.1520
Decision codeDENG
Submission typeDirect

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

De Novo is the pathway for novel low-to-moderate-risk devices with no predicate. A granted De Novo creates a new device classification that later devices can use as a predicate. GI Genius went through this pathway (DEN200055).

openFDA lists it as a Class 2 device under 21 CFR 876.1520. Class II devices are moderate risk and are subject to general and special controls.

Product code QNP covers 20 devices on the FDA AI list. By decision date, this device is #1 of 20 under that code. Cosmo Artificial Intelligence - AI, LTD has 6 AI-enabled devices on the list, and the Gastroenterology-Urology panel accounts for 27 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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