Australia Grants Approval For 1st Wearable Stethoscope for Pediatric Use

The device is designed to support respiratory monitoring in pediatric patients, particularly those with conditions such as asthma, whose symptoms fluctuate or worsen between clinic appointments.

Singapore-based healthcare Startup Aevice Health has received approval from Australia's Therapeutic Goods Administration for its AI-powered respiratory monitoring system in individuals aged 3 and above.

The device, known as AeviceMD, integrates several functions, including digital auscultation, wheeze detection, and heart and respiratory rate measurement, into a single Class IIa medical device.

The device is designed to support respiratory monitoring in pediatric patients, particularly those with conditions such as asthma, whose symptoms fluctuate or worsen between clinic appointments.

Reportedly, the device approval was supported by data from an observational study conducted with Singapore’s National University Hospital, where the device demonstrated visibly improved results and accuracy in detecting wheezing among children.

Pilot deployments have shown promising results in supporting continuous respiratory monitoring and enabling early detection of symptom deterioration.

Further, the wearable system pairs with mobile and web applicationswhich are expected to enable clinicians to monitor patients outside traditional healthcare settings.

This approach seeks to reduce the need for frequent in-person visits while supporting timely intervention when symptoms change.

The new approval in Australia follows its prior regulatory clearance from the U.S. Food and Drug Administration for paediatric use of the same wearable stethoscope.

Commenting on the new grant, CEO Ang said, Aevice Health, “With its new TGA clearance, 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.”

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