Approval obtained by Aevice Health for a pediatric wearable digital stethoscope from the FDA
The AeviceMD, a smart wearable stethoscope designed for remote monitoring of lung sounds, has received U.S. Food and Drug Administration (FDA) 510(k) clearance to be used 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 serves as a hospital-at-home tool, supporting earlier interventions, reducing readmissions, and extending care beyond traditional clinical settings. Adrian Ang, CEO of Aevice Health, stated that the FDA clearance extends the company's reach to young children and is a significant step forward in their commitment to reshape home-based respiratory disease management.
The AeviceMD is designed to allow real-time respiratory monitoring remotely, potentially improving early detection of respiratory distress in children with chronic or acute respiratory conditions. It enables clinicians to monitor patients with chronic respiratory diseases from home, enabling early detection of respiratory exacerbations.
Aevice Health plans to accelerate its commercialization efforts following this pediatric clearance, with a focus on expanding enterprise partnerships and home care programs. The AeviceMD is currently deployed across leading hospitals in the U.S. and Singapore.
Meanwhile, other advancements in the respiratory monitoring field include AccurKardia's AI-powered hyperkalemia detection solution, which has received FDA breakthrough device designation. electronRx is planning to launch a smartphone app for remote lung function monitoring, offering another option for remote respiratory disease management.
Despite the lack of detailed device specifications, functionalities, or clinical performance data in available search results, Aevice Health is known for developing wearable respiratory monitoring devices aimed at home use, especially for pediatrics, that leverage acoustic sensors to monitor respiratory rate and other related parameters continuously and noninvasively.
For more detailed information about the Aevice Health’s system, including device specifications, functionalities, or the exact scope of the FDA clearance, it is recommended to consult the company’s official press releases or the FDA’s 510(k) database for the specific clearance documents.
These news articles are featured in "Digital Health & AI News".
- The AeviceMD, which is a part of the medical-conditions category, is a smart wearable stethoscope designed for monitoring lung sounds, a piece of technology that falls under the broader umbrella of health-and-wellness, particularly focusing on home-based respiratory disease management.
- In the field of digital health, Aevice Health, a company committed to reshaping home-based respiratory disease management through science and technology, recently received FDA 510(k) clearance for its AeviceMD, allowing it to be used in pediatric patients, thus extending its reach to young children.
- The AeviceMD, a tool for digital health that leverages acoustic sensors for continuous and noninvasive monitoring of respiratory rate and related parameters, has the potential to improve early detection of respiratory distress in children, contributing significantly to medical-conditions management and the overall health-and-wellness industry.
