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.
Aevice says the regulatory milestone follows the closing of its seed-plus round in late 2024. It currently has its device deployed across hospitals in the U.S. and Singapore but plans to accelerate commercialization following the pediatric clearance. The company wants to emphasize its focus on expanding enterprise partnerships and home care programs.
“This FDA clearance extends our reach to one of the most vulnerable patient groups — young children,” said Adrian Ang, Aevice Health CEO. “It is a major step forward in our commitment to reshape how respiratory diseases are managed at home. “We’re excited to work with our partners in the U.S. to bring this technology into homes and hospitals nationwide.”
This clearance means more competition for the smart stethoscope market in the U.S., which includes Eko Health and its AI-based Sensora digital stethoscope system.
