Photo courtesy of Aevice Health
Singaporean startup Aevice Health has received approval from Australia's Therapeutic Goods Administration for the use of its AI-powered respiratory monitoring system in individuals aged 3 and above.
It represents the first approval of its kind in the country for a device that integrates wheeze detection, heart and respiratory rate measurement, and digital auscultation into a single Class IIa medical device for patients above 3 years, Aevice claimed in a media statement.
The approval also meant the inclusion of the AeviceMD into the Australian Register of Therapeutic Goods. The startup was granted expedited registration as the TGA recognises Singapore’s Health Sciences Authority – which provided its first regulatory clearance – as a Comparable Overseas Regulator, CEO Adrian Ang told Mobihealth News. "Aevice Health has leveraged this pathway for market access into Australia," he said.
The Australian regulator also cited findings from Aevice's observational study with National University Hospital in Singapore, which showed that the AI-powered wearable stethoscope achieved 92% detection accuracy in a paediatric cohort.
WHY IT MATTERS
About 11% of Australians, or around 2.8 million, have been living with asthma in Australia, based on the latest 2022
Australian Institute of Health and Welfare data.
With its new TGA clearance, CEO Ang said, Aevice will explore potential pilot deployments and workflow integrations with local hospitals, respiratory specialists, and clinical teams.
"These discussions will focus on incorporating respiratory monitoring into existing asthma management pathways in the outpatient care model for their remote patient or therapeutic monitoring programs," he emphasised.
As it monitors patients across various care settings, the AeviceMD device and companion applications allow healthcare teams to extend monitoring outside medical settings. It also assists with the early identification of symptom deterioration while reducing the need for frequent in-person visits.
Beyond Australia, the startup will continue looking for opportunities to expand across the Asia-Pacific and other international markets. Aevice has also made moves to enter the Japanese market, which is one of its key targets.
THE LARGER TREND
In May, Aevice secured a second 510(k) clearance from the United States Food and Drug Administration, extending the use of its wearable stethoscope to children aged 3 and above, after receiving its first approval in 2023.
Its global expansion has been backed by multiple funding rounds raised over the past few years, including last year's $7 million seed funding.
