An ingestible capsule designed to measure gas levels in the gut – originally developed at RMIT – has received regulatory approval for use in the United States.
The Atmo Gas Capsule, developed to assist with diagnosing gastrointestinal disorders such as gastroparesis and slow transit constipation, has been cleared by the U.S. Food and Drug Administration (FDA). The device provides real-time data as it travels through the digestive system, offering a less invasive and more accurate tool for clinicians to assess gut health.
The technology was invented at RMIT and licensed to Atmo Biosciences in 2018. Since then, Atmo has transformed the capsule from a research concept into a clinically validated product.
Atmo Biosciences CEO and president Mal Hebblewhite said the approval marked a significant milestone for patients and clinicians alike.
“We are thrilled to have achieved FDA clearance for this important initial indication in motility,” Mr 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 FDA 510(k) clearance follows the successful completion of a pivotal clinical study involving more than 200 participants across 12 trial sites in the US and Australia. The study demonstrated the safety and efficacy of the capsule.
Distinguished Professor Calum Drummond AO, RMIT deputy vice-chancellor research and innovation and vice-president, said the invention highlights the university’s focus on impact-driven research.
“We are particularly proud that several of our students and early career researchers played instrumental roles in developing this technology at RMIT and have continued to contribute as co-founders at Atmo Biosciences,” Professor Drummond said.
The Atmo Gas Capsule System will be commercially available in the United States from July 2025.