Device Tracker
FDA-Cleared AI Devices in Gastroenterology
Real-time computer-aided detection during endoscopy.
| Device | Manufacturer | Route | Year | Modality | Function |
|---|---|---|---|---|---|
| GI Genius | Medtronic | De Novo | 2021 | Colonoscopy video | Marks suspected polyps during live colonoscopy |
| SKOUT | Iterative Health | 510(k) | 2022 | Colonoscopy video | Real-time computer-aided polyp detection |