Melbourne medtech Atmo Biosciences has received US Food and Drug Administration clearance for its Atmo Gas Capsule, a vitamin sized device that patients swallow to help doctors diagnose gut motility disorders. The 510(k) clearance was announced in June 2025.
Motility disorders such as gastroparesis and slow transit constipation affect millions of people, many of whom wait years for a clear diagnosis. Testing has typically relied on hospital procedures such as gastric scintigraphy, in which the patient eats a meal containing a radioactive tracer and is imaged under a scanner. Atmo’s capsule is designed to gather similar information while the patient goes about their normal day.
How the capsule works
The capsule senses gases as it travels through the digestive tract and transmits the data wirelessly. From those readings, clinicians can see how quickly material moves through the stomach, small bowel and colon, a measure known as transit time, without the need for a scope.
“The Atmo Gas Capsule is a much-needed test that gives clinicians comprehensive, clinically valuable information,” chief executive and president Mal Hebblewhite said, as reported by Australian Manufacturing. He described the FDA decision as clearance for an “initial indication in motility”.
From RMIT to the FDA
The technology was developed at RMIT University in Melbourne and licensed to Atmo Biosciences in 2018. RMIT has said several of its students and early career researchers played key roles in the work and went on to become co-founders of the company.
The clearance followed a pivotal clinical study that enrolled 209 participants across 12 sites, 11 in the US and one in Australia. The company said the study met its primary endpoints. Atmo said it expected the capsule to become commercially available in the US from July 2025.
The backing
Atmo closed a fully subscribed $8 million Series B round led by Japanese pharmaceutical company Otsuka, an existing shareholder, according to BioMelbourne Network. Hebblewhite has said the company is investigating what else the capsule’s gas readings can detect beyond motility.
Regulatory clearance is a significant hurdle for any diagnostic device, but adoption is a separate test. Atmo will now need US gastroenterologists and insurers to accept the capsule in place of established procedures.
Jack’s take
A team out of a Melbourne university shrank a hospital test into something that fits in a pill bottle, and got it past the FDA. That is the hard part for most medtech startups and a lot of them never get there. What I want to see next is whether US doctors actually change how they diagnose, because that is where the revenue lives.