AeviceMD Monitoring System, a non-invasive wearable respiratory monitoring solution developed by Singapore-based Aevice Health, has been included in the Australian Register of Therapeutic Goods (ARTG) as a Class IIa medical device. This milestone marks an important step in Aevice Health’s expansion into the Australian market.
Inclusion in the ARTG confirms that the AeviceMD Monitoring System meets Australia’s regulatory requirements for safety, quality, and performance, allowing it to be supplied in Australia in accordance with its approved intended use. With this, the AeviceMD Monitoring System becomes the first device of its kind in Australia to integrate wheeze detection, measurements of heart and respiratory rate, and digital auscultation into a single, lightweight device for patients aged three years and above.
"Asthma affects approximately 2.8 million people in Australia, representing one of the higher prevalence rates globally. We see this as a meaningful opportunity to work alongside clinicians and partners to help support better respiratory care outcomes. This milestone allows us to take a thoughtful and responsible step toward serving patients and healthcare systems in Australia,” said Adrian Ang, CEO of Aevice Health.
