TGA Certification Granted to Aevice Health’s Wearable Stethoscope

Australia’s Therapeutic Goods Administration has approved a non-invasive wearable respiratory monitoring solution developed by Aevice Health. Registered as a Class IIa medical device, the AeviceMD Monitoring System marks the company’s expansion into the Australian market.

Inclusion in the Australian Registry of Therapeutic Goods (ARTG) confirms the AeviceMD Monitoring System meets the country’s regulatory requirements for safety, quality, and performance, allowing it to be marketed in Australia. Consequently, the AeviceMD Monitoring System is now the first device of its kind in Australia to integrate wheeze detection, heart and respiratory rate measurements, and digital auscultation into a single, lightweight device for patients aged 3 years and older.

“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,” Aevice Health CEO Adrian Ang said.

Singapore-based Aevice Health is a digital health company working to improve asthma and COPD care through its proprietary, non-invasive remote patient monitoring platform and wearable stethoscope, the AeviceMD. Its technology allows for continuous monitoring and real-time disease deterioration tracking, enabling patients to receive personalized care from their homes. With actionable insights and effortless treatment response monitoring, healthcare professionals can make timely adjustments for optimized patient outcomes. Aevice Health strives to improve healthcare accessibility, empower patients, and reduce healthcare costs.