Australian company Atmo Biosciences has received US FDA 510(k) clearance for its gas capsule system, meaning it can be marketed and sold in the country.
The Atmo Gas Capsule offers clinicians a convenient solution for assessing both whole-gut and regional transit times, encompassing the stomach, small intestine, and colon, to aid in diagnosing gastrointestinal motility disorders.
These disorders include gastroparesis, which is characterised by delayed stomach emptying, 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’s decision was based on a clinical study in which 209 subjects across 12 sites in the US and Australia ingested both the Atmo Gas Capsule and a predicate device. 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 and 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 commercially available in the US starting in July 2025.