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# Aevice Health secures FDA clearance for paediatric wearable stethoscope device
- URL: https://med-techinsights.com/aevicemd-receives-fda-clearance-for-paediatric-use/
- Published: 2025-05-19T08:41:55.000Z
- Updated: 2026-10-22T07:49:23.000Z
- Description: Aevice Health has announced that its flagship medical device, the AeviceMD, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for use in paediatric patients aged 3 years and above. The clearance marks a significant milestone in Aevice Health’s mission to deliver continuous, home-
- Author: Oliver Johnson
- Tags: Medical Device Manufacturing, News

[**Aevice Health**](https://www.aevice.com/us/md?ref=med-techinsights.com) has announced that its flagship medical device, the AeviceMD, has received [**U.S. Food and Drug Administration**](https://www.fda.gov/?ref=med-techinsights.com) (FDA) 510(k) clearance for use in paediatric 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 forremote monitoring of lung sounds, enabling early detection of respiratory exacerbations by clinicians. Its clinically validated AI and paediatric-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.

“This FDA clearance extends our reach to one of the most vulnerable patient groups — young children. It is a major step forward in our commitment to reshape how respiratory diseases are managed at home,” said Adrian Ang, CEO of Aevice Health. “We’re excited to work with our partners in the U.S. to bring this technology into homes and hospitals nationwide.”

This regulatory milestone follows Aevice Health’s successful closing of its Seed Plus round in late 2024, led by Coronet Ventures, the U.S. venture arm of Cedars-Sinai Intellectual Property. The round also saw participation from institutional and corporate investors including SEEDS Capital, East Ventures, Denka Company, A&D Company, and Elev8 VC.

The AeviceMD is currently deployed across leading hospitals in the U.S. and Singapore. The company plans to accelerate its commercialisation efforts following this paediatric clearance, with a focus on expanding enterprise partnerships and home care programs.