An innovative gas-sensing capsule developed at RMIT University to provide real-time insights into gut health has received regulatory clearance from the US Food and Drug Administration (FDA), paving the way for its commercial launch in the United States.
The Atmo Gas Capsule, which measures gases as it travels through the digestive system, is designed to assist in diagnosing gastrointestinal disorders such as gastroparesis and slow transit constipation.
These conditions, affecting millions worldwide, are often difficult to diagnose using current methods, RMIT said in a news release.
The ingestible capsule originated from research conducted at RMIT and was licensed to Atmo Biosciences in 2018. Since then, the company has advanced the technology through development, manufacturing, and clinical trials to create a market-ready solution.
“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 FDA’s 510(k) clearance follows the successful completion of a pivotal clinical study involving over 200 participants across 12 sites in the United States and Australia.
The study confirmed the device’s safety and effectiveness in providing diagnostic insights into gut function.
RMIT Deputy Vice-Chancellor Research and Innovation and Vice-President, Distinguished Professor Calum Drummond AO, welcomed the announcement, noting the university’s commitment to translating research into practical solutions.
“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,” Drummond said.
The Atmo Gas Capsule System is expected to be commercially available in the United States starting July 2025.
