An ingestible gas-sensing capsule invented at RMIT to provide real-time insights into gut health is now cleared for use in the United States.
The Atmo Gas Capsule - which helps diagnose gut disorders from gases it measures while travelling through the digestive system - has just received regulatory clearance from the U.S. Food and Drug Administration.
Originally invented through ground-breaking research at RMIT, the ingestible gas-sensing capsule was licensed by Atmo Biosciences in 2018.
Since then, the company has advanced the technology from concept to clinical reality.
Atmo has developed, manufactured and trialled the device to create a market-ready solution for diagnosing gastrointestinal disorders like gastroparesis (delayed emptying from the stomach) and slow transit constipation, which affect millions of individuals worldwide.
The ingestible capsule measures specific gases in the gut then transmits data for assessment.
Atmo Biosciences CEO & President, Mal Hebblewhite, said the FDA clearance enables Atmo to address a large unmet clinical need in diagnosing these conditions, which can remain undiagnosed or misdiagnosed for years.
"We are thrilled to have achieved FDA clearance for this important initial indication in motility," he 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 was based on last year's successful completion of a pivotal clinical study demonstrating the safety and efficacy of the device on more than 200 subjects from 12 trial sites in the US and Australia.
Distinguished Professor Calum Drummond AO and Mal Hebblewhite at RMIT University for the transfer of IP ownership in April 2025.
RMIT Deputy Vice-Chancellor Research and Innovation and Vice-President, Distinguished Professor Calum Drummond AO, said the success of this invention exemplified the university's mission to translate academic research for social benefit.
"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 will be available commercially in the USA from July 2025.
