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# Atmo Bio’s Gut Capsule Cleared by FDA
- URL: https://www.fdaweb.com/atmo-bios-gut-capsule-cleared-by-fda/
- Published: 2025-06-27T12:00:00.000Z
- Updated: 2026-09-14T15:15:26.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159434

FDA has cleared an Atmo Biosciences 510(k) for the ingestible Atmo Gas Capsule System for assessing both whole and regional gut transit times — covering the stomach, small bowel, and colon — as an aid in diagnosing gastrointestinal motility disorders (gastroparesis and slow transit constipation). “By measuring regional and whole gut transit, the capsule eliminates the need for more cumbersome procedures such as gastric scintigraphy or radio-opaque marker studies, and avoids exposing patients to radiation,” the company says.

FDA’s clearance was based on a pivotal clinical study in which 209 subjects ingested both the Atmo Gas Capsule and a predicate device (Medtronic’s now-discontinued SmartPill), Atmo says. “The study met all endpoints, demonstrating the Atmo Gas Capsule’s equivalence in assessing gastric emptying time and colonic transit time,” it says. The SmartPill was discontinued in 2023 due to supply chain issues and the “maturity of the system,” according to Medtronic. 

Once ingested, the Atmo capsule continuously transmits data to a receiver. The patient’s physician uploads the data to the cloud for aggregation, analysis and patient reporting, the company says.