Atmo Biosciences has received US Food and Drug Administration (FDA) 510(k) regulatory clearance for its Atmo Gas Capsule System, enabling the company to begin marketing and sales in the United States. The clearance covers an initial indication to assist in diagnosing gastrointestinal motility disorders, including gastroparesis and slow transit constipation.
The decision was underpinned by a pivotal clinical study which met all its endpoints, demonstrating the Atmo capsule’s equivalence to existing technologies. The capsule will be available commercially in the US from July 2025.
“We are thrilled to have achieved FDA clearance for this important initial indication in motility,” Atmo Biosciences CEO and President said Malcolm Hebblewhite said. “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 clearance followed a multi-centre clinical study involving 209 participants across 12 sites — 11 in the United States and one in Australia.
Participants ingested both the Atmo Gas Capsule and a predicate device (SmartPill). The study demonstrated that Atmo’s capsule is equivalent in measuring gastric emptying and colonic transit times.
Convenient tool for diagnosing motility disorders
The Atmo Gas Capsule provides a novel way to assess gut transit times across the stomach, small intestine, and colon.
Its data allows clinicians to diagnose common gastrointestinal motility disorders without resorting to invasive procedures like gastric scintigraphy or radio-opaque marker tests.
The capsule's key advantage lies in its ease of use: patients can continue normal daily activities during the test, and it eliminates radiation exposure.
Gastrointestinal motility disorders affect millions globally and often go undiagnosed or are misdiagnosed, leading to prolonged suffering. Symptoms such as nausea, vomiting, bloating, abdominal pain, and irregular bowel habits significantly affect patients’ quality of life. With this FDA clearance, Atmo aims to bridge a diagnostic gap, offering clinicians a fast and reliable solution.
About Atmo Biosciences
Atmo Biosciences is a medical device and digital health company focused on ingestible capsule technology for gut health. Its flagship product, the gas-sensing capsule, is designed to assist gastroenterologists in diagnosing motility disorders by measuring gut transit times. The technology is also being deployed in clinical research trials globally.
More at: www.atmobiosciences.com