Aevice wins FDA nod for smart wearable stethoscope for pediatric patients

Aevice Health announced today that it received FDA 510(k) clearance for its AeviceMD smart wearable stethoscope device.

The FDA cleared AeviceMD for use in pediatric patients aged three years and above. The company says clearance marks a significant milestone in its mission to deliver continuous, home-based respiratory monitoring. It aims to bring its device to vulnerable populations, including young children with asthma and other chronic respiratory conditions.

Singapore-based Aevice designed its stethoscope for remote monitoring of lung sounds, enabling early detection of respiratory exacerbations. The device features clinically validated AI and a pediatric-friendly design to deliver objective data to monitor chronic respiratory diseases from home. As a hospital-at-home tool, AeviceMD supports earlier interventions, reduces readmissions and extends care beyond traditional settings.

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