Ingestible gut gas diagnostic device cleared for sale in the US

An invention born at RMIT University will go on sale for the first time ever in July, following regulatory approval from the US Food and Drug Administration for an ingestible capsule that can help diagnose gut disorders.

According to a statement from RMIT on Monday, Atmo Biosciences’ device has moved “from concept to clinical reality” since being licenced from the university in 2018. 

The FDA 510(k) clearance was based on successful completion of a clinical study last year demonstrating the safety and efficacy of the device on more than 200 subjects from 12 trial sites in the US and Australia.

Atmo has developed, manufactured and trialled the device, which is now a “market-ready solution for diagnosing gastrointestinal disorders like gastroparesis” and slow transit constipation, affecting millions worldwide.

“We are thrilled to have achieved FDA clearance for this important initial indication in motility,” Atmo Biosciences CEO & President, Mal 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 news follows an announcement in April that “all patents and associated intellectual property” related to the Atmo Gas Capsule had been transferred from RMIT “in exchange for an equity stake in the company.”

According to Atmo, its capsule “measures gases as it travels through the gastrointestinal tract and transmits the data wirelessly” and was first built as lab prototypes and tested at RMIT labs in 2011.

Picture: supplied

Further reading

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Health tech commercialisation centre opens in Melbourne CBD

RMIT transfers all IP for gas capsule to Atmo Biosciences in exchange for equity

Breakthrough Victoria invests in gut gas detection startup