Gastroenterology-Urology · 2025

FDA-cleared AI devices for gastroenterology-urology 2025

2025 has 8 gastroenterology-urology AI devices, 60% more than 2024 (5). That is 29.6% of the 27 gastroenterology-urology devices on the FDA list, and 2.4% of all AI-device decisions dated 2025. The most active were Iterative Health (2), Magentiq Eye, Ltd. (2), Alimetry, Ltd. (1). The newest is SKOUT system from Iterative Health, decided on December 22, 2025.

82025 devices
6Companies
2.4%Of all 2025 AI devices
29.6%Of all gastroenterology-urology

Companies in 2025

By month

Jan: 1Feb: 0Mar: 0Apr: 0May: 1Jun: 2Jul: 0Aug: 0Sep: 1Oct: 1Nov: 0Dec: 2
JanFebMarAprMayJunJulAugSepOctNovDec
Gastroenterology-Urology AI devices by month in 2025: Jan 1, Feb 0, Mar 0, Apr 0, May 1, Jun 2, Jul 0, Aug 0, Sep 1, Oct 1, Nov 0, Dec 2

Product codes

QNPGastrointesinal Lesion Software Detection System5MYESystem, Electrogastrography (Egg)1QZBSoftware Controlled Endoscope And Instrument Holder1SFEEndoscopic Video Imaging System / Software Component For Real Time Video Augmentation1

All 8 devices

All gastroenterology-urology devicesAll AI clearances in 2025Top gastroenterology-urology AI devices20245

Frequently asked questions

How many FDA-cleared AI gastroenterology-urology devices were there in 2025?

8 AI-enabled gastroenterology-urology devices have a final decision dated 2025, from 6 companies.

How does 2025 compare with 2024 for AI gastroenterology-urology devices?

2025 has 8 gastroenterology-urology AI devices, 60% more than 2024 (5).

Which companies cleared the most AI gastroenterology-urology devices in 2025?

Iterative Health (2), Magentiq Eye, Ltd. (2), Alimetry, Ltd. (1).

What was the most recent AI gastroenterology-urology device in 2025?

SKOUT system from Iterative Health (K253664), decided on December 22, 2025. Product code QNP.

Which product codes were most common for AI gastroenterology-urology devices in 2025?

QNP (Gastrointesinal Lesion Software Detection System): 5; MYE (System, Electrogastrography (Egg)): 1; QZB (Software Controlled Endoscope And Instrument Holder): 1.

Cite as: AI Device Radar, “FDA-cleared AI devices for gastroenterology-urology 2025,” https://ai-device-radar.vercel.app/specialty/gastroenterology-urology/2025 (FDA list through 2026-06-29).