The U.S. Food and Drug Administration has granted 510(k) clearance to the Atmo Gas Capsule, an ingestible diagnostic device that measures gases throughout the digestive system to help diagnose gastrointestinal motility disorders. The technology, originally developed at RMIT University, represents a significant advancement in diagnosing conditions like gastroparesis and slow transit constipation that affect millions of individuals worldwide.
From Laboratory to Market
The journey from academic research to commercial reality began with groundbreaking work at RMIT, where the gas-sensing capsule was first built as laboratory prototypes and tested in 2011. Atmo Biosciences licensed the technology from the university in 2018 and has since advanced it through clinical development to create a market-ready diagnostic solution.
The FDA clearance enables the device to go on sale for the first time in July 2025, marking a milestone for both the company and patients suffering from often misdiagnosed gastrointestinal conditions.
Clinical Validation and Regulatory Approval
The FDA 510(k) clearance was based on successful completion of a pivotal clinical study that demonstrated the safety and efficacy of the device. The study involved more than 200 subjects across 12 trial sites in the United States and Australia, providing robust evidence for the capsule's diagnostic capabilities.
"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."
Addressing Unmet Clinical Needs
The device targets a significant gap in gastrointestinal diagnostics, particularly for gastroparesis (delayed emptying from the stomach) and slow transit constipation. These conditions can remain undiagnosed or misdiagnosed for years, leaving patients without appropriate treatment options.
According to Hebblewhite, the FDA clearance enables Atmo to address a large unmet clinical need in diagnosing these conditions. The capsule measures gases as it travels through the gastrointestinal tract and transmits the data wirelessly, providing clinicians with detailed information about digestive function.
Technology Transfer and Commercialization
The commercialization process involved a complete transfer of intellectual property from RMIT to Atmo Biosciences. In April, all patents and associated intellectual property related to the Atmo Gas Capsule were transferred from RMIT in exchange for an equity stake in the company, solidifying the partnership between the academic institution and the commercial entity.
This technology transfer model demonstrates how university research can successfully transition to market applications, bringing innovative medical devices from laboratory concepts to clinical reality.
