Australia Grants First Approval for a Wearable Stethoscope for Children

Aevice Health, a Singapore-based respiratory monitoring startup, has become the first company in Australia to secure Therapeutic Goods Administration approval for a wearable stethoscope designed for children aged three and above. The device, AeviceMD, integrates continuous respiratory monitoring, digital auscultation, wheeze detection, and heart and respiratory rate measurement into a single Class IIa medical device—marking the first clearance of its kind for paediatric use in the country.

The approval adds AeviceMD to the Australian Register of Therapeutic Goods and was expedited under Australia’s Comparable Overseas Regulator pathway. The TGA recognises Singapore’s Health Sciences Authority, which granted the device its initial regulatory clearance, enabling Aevice to accelerate its route to market. Supporting evidence included an observational study conducted with Singapore’s National University Hospital, where the wearable achieved 92% wheeze-detection accuracy in a paediatric cohort.

Asthma remains one of Australia’s most common chronic conditions, affecting around 2.8 million people, or 11% of the population. With its new clearance, Aevice plans to engage hospitals, respiratory specialists, and clinical teams to explore pilot deployments and workflow integrations. CEO Adrian Ang said these discussions will centre on embedding continuous respiratory monitoring into outpatient asthma management and remote patient monitoring pathways. Such integration would allow clinicians to detect symptom deterioration earlier and reduce unnecessary in-person visits.

The AeviceMD system pairs the wearable sensor with mobile and web applications, enabling clinicians to monitor patients across a range of care settings. By extending visibility outside traditional environments, the platform aims to close gaps in paediatric asthma management—particularly for children whose symptoms fluctuate or worsen between clinic appointments.

Australia is one step in a broader international expansion strategy for the company. Aevice is actively pursuing opportunities across Asia-Pacific and other global markets, with Japan identified as a key priority. The progress follows a period of regulatory and commercial momentum: the company secured a second FDA 510(k) clearance in May, extending the device’s US use to children aged three and above, and has raised multiple funding rounds, including a $7 million seed round last year.

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