Aevice Health Secures US FDA Clearance for Pediatric Use of AeviceMD, a Remote Respiratory Monitoring Platform Enabled by Smart Wearable Stethoscope
Singapore, 19 May 2025 — Aevice Health, a MedTech company pioneering remote respiratory monitoring solutions, announced today that its flagship medical device, the AeviceMD, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for use in pediatric patients aged 3 years and above. The clearance marks a significant milestone in Aevice Health’s mission to deliver continuous, home-based respiratory monitoring for vulnerable populations, including young children with asthma and other chronic respiratory conditions. The AeviceMD is a smart wearable stethoscope designed for remote monitoring of lung sounds, enabling early detection of respiratory exacerbations by clinicians. Its clinically validated AI and pediatric-friendly design provide clinicians with, objective data to monitor patients with chronic respiratory diseases from home. As a hospital-at-home tool, AeviceMD supports earlier interventions, reduces readmissions, and extends care beyond traditional clinical settings.
