Atmo Biosciences has been granted clearance by the United States Food and Drug Administration (FDA) under the 510(k) process for its Atmo Gas Capsule System, enabling its first product to be marketed and sold in the United States.
This regulatory milestone was regarded as a pivotal advancement in the company’s commercial strategy to deliver its ingestible diagnostic technology to broader healthcare markets globally. The Atmo Gas Capsule provided clinicians with a practical method to evaluate both total and segmental gastrointestinal transit times—encompassing the stomach, small intestine, and colon—to support the diagnosis of gastrointestinal motility disorders. These included conditions such as gastroparesis, where delayed stomach emptying occurs, and slow transit constipation. By measuring both regional and whole gut transit, the capsule removed the need for more invasive procedures such as gastric scintigraphy or radio-opaque marker studies, and avoided patient exposure to radiation. It was noted that patients undergoing testing with the capsule could continue with their normal daily routines.
The FDA’s decision had been underpinned by a pivotal clinical investigation involving 209 participants across 12 locations (11 in the US and one in Australia). Atmo reported in 2024 that the trial achieved its primary objectives, and subsequent analyses confirmed its utility for assessing gastrointestinal transit to aid clinical evaluation.
“We were thrilled to have received FDA clearance for this essential initial indication in motility,” said Mal Hebblewhite, Chief Executive Officer and President of Atmo Biosciences. “This capsule provided clinicians with comprehensive, clinically meaningful information to diagnose and manage patients swiftly, conveniently, and accurately.”
The Atmo Gas Capsule System is expected to become commercially available in the United States from July 2025.
