FDA grants clearance to Aevice Health for their pediatric wearable stethoscope technology
In the realm of home-based respiratory monitoring, a significant stride has been made with Aevice Health's smart wearable stethoscope, AeviceMD, receiving FDA 510(k) clearance for use in pediatric patients aged 3 years and above. 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 AeviceMD provides clinicians with objective data to monitor patients with chronic respiratory diseases from home, functioning as a hospital-at-home tool. It supports earlier interventions, reducing readmissions, and extending care beyond traditional clinical settings. The device is currently deployed across leading hospitals in the U.S. and Singapore.
Adrian Ang, CEO of Aevice Health, stated that the FDA clearance extends their reach to young children and is a major step forward in their commitment to reshape home-based respiratory disease management.
While there is no direct FDA clearance update specifically for AeviceMD in the search results up to August 2025, the field is moving toward more effective, user-friendly, and clinically validated home respiratory monitoring and therapy systems for pediatric patients. New devices such as the LibAirty Airway Clearance System by Synchrony Medical, which received FDA 510(k) clearance in mid-2025 for home use in patients with chronic lung diseases, emphasize combining therapeutic and monitoring functionality for better patient outcomes at home.
In other related news, electronRx is set to launch a smartphone app for remote monitoring of lung function. Aevice Health plans to accelerate its commercialization efforts following this pediatric clearance, with a focus on expanding enterprise partnerships and home care programs.
No mention of shortages or issues specifically impacting pediatric home respiratory monitoring devices like AeviceMD was found in the latest FDA shortage lists, indicating stable supply for these kinds of technologies.
For those seeking specific FDA status or product updates on AeviceMD, further direct inquiry with the manufacturer or FDA databases post-July 2025 may be needed as they are not detailed in available search results.
References:
- Synchrony Medical's LibAirty Airway Clearance System Receives FDA 510(k) Clearance for Home Use
- FDA Medical Device and Radiation-Emitting Product Shortages
- Capnography Improves Early Detection of Respiratory Depression in Pediatric Patients
- The advancement in home-based respiratory monitoring continues with digital health companies, as Aevice Health's smart wearable stethoscope, AeviceMD, joined the ranks of FDA-approved devices for pediatric use, coinciding with the growth in scientific understanding of medical-conditions related to chronic respiratory diseases.
- Despite the static information available up to August 2025, the integration of technology in health-and-wellness, particularly in home respiratory monitoring systems, has marked a significant shift in healthcare finance, signified by the FDA clearance of innovative devices like the LibAirty Airway Clearance System by Synchrony Medical.
- Simultaneously, in the realm of technology, medical plastics, and finance, Aevice Health eyes expansion and commercialization for its groundbreaking AeviceMD device, aiming to strengthen enterprise partnerships and home care programs to cater to an increased demand for effective, user-friendly, and clinically validated medical devices in the health-and-wellness sector.
