Aussie-invented smart capsule wins regulatory nod

An ingestible gas-sensing capsule originally developed at RMIT University has received regulatory clearance from the U.S. Food and Drug Administration (FDA), opening the door to its commercial release across the United States.

The Atmo Gas Capsule, which detects and analyses gases as it travels through the digestive tract, provides clinicians with real-time insights into gut function. The medical device is designed to support the diagnosis of gastrointestinal motility disorders such as slow transit constipation, which often remain undiagnosed or misdiagnosed for years.

“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 more than 200 participants across 12 sites in the US and Australia. The results demonstrated the capsule’s safety and clinical efficacy in diagnosing gut motility disorders.

Atmo Biosciences licensed the capsule from RMIT in 2018, following a decade of pioneering research. Since then, the Melbourne-based company has advanced the capsule into a commercially ready product with support and funding from MTPConnect’s BMTH accelerator.

“It’s been a 15-year journey for this Melbourne-born startup out of RMIT University, and, like so many, the company’s commercialisation story is one of determination and collaboration,” said Stuart Dignam, CEO of MTPConnect.

The capsule’s underlying technology was invented at RMIT, and in April this year, the university transferred all associated patents and intellectual property to Atmo Biosciences in exchange for equity. The move highlights RMIT’s commitment to commercialising academic 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,” said Distinguished Professor Calum Drummond AO, RMIT’s Deputy Vice-Chancellor Research and Innovation and Vice-President. “The success of this invention exemplifies the university’s mission to translate academic research for social benefit.”

Atmo Biosciences plans to launch the Atmo Gas Capsule commercially in the United States from July 2025, offering clinicians a novel and non-invasive diagnostic tool to tackle gastrointestinal disorders.

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