The Atmo Gas Capsule offers clinicians a convenient solution for assessing both whole and regional gut transit times—covering the stomach, small bowel, and colon—to aid in diagnosing gastrointestinal motility disorders.
These include gastroparesis (delayed emptying from the stomach) and slow transit constipation, both of which are treatable conditions. 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. During the Atmo test, patients can go about their normal daily activities.
Motility disorders affect millions of individuals worldwide, causing debilitating symptoms like nausea, vomiting, bloating, abdominal pain, and abnormal bowel habits. The FDA clearance enables Atmo to address a large unmet clinical need in diagnosing these conditions, which can remain undiagnosed or misdiagnosed for years.
The FDA’s decision was based on a pivotal clinical study in which 209 subjects across 12 sites (11 in the U.S. and 1 in Australia) ingested both the Atmo Gas Capsule and a predicate device (SmartPill). The study met all endpoints, demonstrating the Atmo Gas Capsule’s equivalence in assessing gastric emptying time and colonic transit time.
“We are thrilled to have achieved FDA clearance for this important initial indication in motility,” said Mal Hebblewhite, CEO & President of Atmo Biosciences.
“The Atmo Gas Capsule is a much-needed test that gives clinicians comprehensive, clinically valuable information so they can diagnose and manage patients quickly, conveniently, and accurately.”
The Atmo Gas Capsule System will be available commercially in the USA from July 2025.
Atmo Biosciences was awarded funding and support through MTPConnect’s BioMedTech Horizons accelerator program, in 2020 and 2022, to develop and commercialise the technology – find out more about their journey in this case study.