The FDA has cleared a hardware-and-software refresh of the first AI system ever authorized for colonoscopy. On May 30, 2026, the agency granted a 510(k) clearance (K261369) to Cosmo Artificial Intelligence - Ai, Ltd. for the GI Genius Module 300 (GGM300-US), paired with ColonPRO US software (CPRO403S-US) — the next generation of the polyp-detection platform Medtronic distributes worldwide.

The clearance is a Special 510(k), the pathway used when a manufacturer modifies a device it already markets, with the agency finding the new module substantially equivalent to its predicate. The submission was received April 27 and cleared in roughly five weeks. It sits under product code QNP — the gastrointestinal-lesion software category that the original GI Genius created when the FDA granted it a De Novo authorization on April 9, 2021. The device is a Class II computer-aided detection (CADe) tool under regulation 21 CFR 876.1520, reviewed by the Gastroenterology-Urology advisory panel.

What this clears, and what it doesn’t

The 510(k) record establishes equivalence and market authorization; it does not, on its own, publish new clinical effectiveness data. The widely cited performance figure for GI Genius — what Medtronic’s 2021 De Novo announcement described as “a 14% absolute increase in ADR compared to colonoscopy alone for both flat (42% increase) and polypoid (36% increase) lesions” — comes from that release for the original module, not from this filing. The release attributes the figure to a single study (Repici et al., Gastroenterology 2020) and does not disclose a sample size, confidence interval, or p-value; it also does not state whether the 42% and 36% lesion-type figures are absolute or relative.

A Special 510(k) clears a hardware-and-software upgrade as substantially equivalent — it is a regulatory equivalence finding, not a fresh efficacy trial.

Medtronic markets GI Genius as the exclusive worldwide distributor of the Cosmo-developed hardware. The companies have not yet posted summary documentation detailing what changed in the Module 300 generation.