Singapore-based Aevice Health announced it has received FDA 510(k) clearance for its AeviceMD smart wearable stethoscope, cleared for use in pediatric patients aged three years and older. This milestone supports Aevice’s mission to enable continuous, home-based respiratory monitoring, particularly for vulnerable children with asthma and other chronic lung conditions.
The device leverages clinically validated AI to remotely monitor lung sounds, aiming to detect early respiratory exacerbations. Designed with a pediatric-friendly approach, AeviceMD delivers objective data to caregivers and clinicians, facilitating earlier interventions, reduced hospital readmissions, and extended care outside traditional settings.
Following a recent funding round, Aevice plans to accelerate commercialization and expand partnerships in both hospital and home care programs across the U.S. and Singapore.
CEO Adrian Ang emphasized the company’s commitment to reshaping respiratory disease management:
“This FDA clearance extends our reach to one of the most vulnerable patient groups — young children… We’re excited to work with our partners in the U.S. to bring this technology into homes and hospitals nationwide.”
The FDA nod adds new competition to the U.S. smart stethoscope market, alongside players like Eko Health with its AI-powered Sensora system.
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