• The AeviceMD secures FDA 510(k) clearance for pediatric use (ages 3+) of AeviceMD, a Class II smart wearable stethoscope medical device.
• This follows a Seed Plus round led by Coronet Ventures with participation from SEEDS Capital, East Ventures, Denka, A&D, and Elev8 VC in 2024.
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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.
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“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 commercialization efforts following this pediatric clearance, with a focus on expanding enterprise partnerships and home care programs.

About Aevice Health
Aevice Health is a digital health company dedicated to improving asthma and COPD care through its proprietary, non-invasive remote patient monitoring platform and wearable stethoscope, the AeviceMD. Its cutting-edge technology aims to allow for continuous monitoring and disease deterioration tracking, enabling patients to receive personalized care from the comfort of their homes. With actionable insights and effortless treatment response monitoring, healthcare professionals can make timely adjustments for optimized patient outcomes. Aevice Health is on a mission to improve healthcare accessibility, empower patients, and reduce healthcare costs.

More information about the company can be found at www.aevice.com.