Roundup · ranked by clearances

Best FDA-cleared AI gastroenterology-urology devices (2026)

The companies with the most FDA-cleared AI gastroenterology-urology devices through June 29, 2026 are Cosmo Artificial Intelligence - Ai, Ltd. (6), Iterative Scopes, Inc. (4) and Magentiq Eye, Ltd. (4). This is a count of final decisions on the FDA list. It is not a ranking of clinical performance.

How this ranking works

Each row is one applicant name on the FDA AI-enabled device list, limited to devices whose lead review panel is Gastroenterology-Urology. Affiliated companies are not merged. A company needs at least two gastroenterology-urology devices to appear in the top list. 9 other companies have exactly one. The full catalog is the gastroenterology-urology specialty page.

Top companies

  1. 1

    Cosmo Artificial Intelligence - Ai, Ltd.

    Cosmo Artificial Intelligence - Ai, Ltd. has 6 FDA-listed AI gastroenterology-urology devices (22.2% of this specialty), with decisions from 2021–2026. The latest is GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US) (K261369) on May 29, 2026. Most common product code: QNP (Gastrointesinal Lesion Software Detection System), 6 devices.

  2. 2

    Iterative Scopes, Inc.

    Iterative Scopes, Inc. has 4 FDA-listed AI gastroenterology-urology devices (14.8% of this specialty), with decisions from 2022–2024. The latest is SKOUT® system (K241508) on July 3, 2024. Most common product code: QNP (Gastrointesinal Lesion Software Detection System), 4 devices.

  3. 3

    Magentiq Eye, Ltd.

    Magentiq Eye, Ltd. has 4 FDA-listed AI gastroenterology-urology devices (14.8% of this specialty), with decisions from 2023–2026. The latest is MAGENTIQ-COLO (ME-APDS) (K260724) on April 3, 2026. Most common product code: QNP (Gastrointesinal Lesion Software Detection System), 4 devices.

  4. 4

    Iterative Health

    Iterative Health has 2 FDA-listed AI gastroenterology-urology devices (7.4% of this specialty), with decisions from 2025. The latest is SKOUT system (K253664) on December 22, 2025. Most common product code: QNP (Gastrointesinal Lesion Software Detection System), 2 devices.

  5. 5

    Odin Medical Limited

    Odin Medical Limited has 2 FDA-listed AI gastroenterology-urology devices (7.4% of this specialty), with decisions from 2024–2025. The latest is CADDIE (K252586) on September 12, 2025. Most common product code: QNP (Gastrointesinal Lesion Software Detection System), 2 devices.

Newest gastroenterology-urology clearances

The six most recent gastroenterology-urology decisions on the list. All specialties in 2026

Radiology1230Cardiovascular154Neurology73Anesthesiology30Hematology22

Frequently asked questions

Which company has the most FDA-cleared AI gastroenterology-urology devices?

Cosmo Artificial Intelligence - Ai, Ltd. has the most, with 6 (22.2% of gastroenterology-urology devices on the list). Next are Iterative Scopes, Inc. (4) and Magentiq Eye, Ltd. (4).

How many FDA-cleared AI gastroenterology-urology devices are there?

The FDA AI-device list has 27 devices with Gastroenterology-Urology as the lead review panel, from 14 companies, through June 29, 2026.

Is this a ranking of the best AI gastroenterology-urology devices clinically?

No. Companies are ordered by how many FDA final decisions they have on the AI-enabled device list. That measures how many authorized products an applicant has, not accuracy, safety, or which device to buy.

Which AI gastroenterology-urology device was cleared most recently?

Instrument Exit Point on Touch Surgery™ Aide from Covidien, LLC (K253984), decided on June 4, 2026.

How many AI gastroenterology-urology devices were cleared in 2026?

2026 does not have a separate gastroenterology-urology page because fewer than five decisions are dated that year.

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