FDA gives green light to Aevice Health for pediatric wearable stethoscope
The healthcare industry has seen a significant shift with the introduction of innovative medical devices, and one such device is the AeviceMD smart wearable stethoscope. This device, designed for continuous lung sound monitoring in pediatric patients, has recently received FDA 510(k) clearance, making it a game-changer for the diagnosis and management of pediatric respiratory conditions.
Device and Use
AeviceMD is a wearable respiratory monitor and stethoscope that helps clinicians detect abnormal respiratory sounds such as wheezing, crackles, and coughs in children. The device is non-invasive, often designed as a patch or chest-worn sensor, enabling continuous auscultation without requiring a traditional handheld stethoscope.
Target Population
The device is primarily cleared for use in pediatric patients, including infants and young children. It supports monitoring of patients with respiratory conditions like asthma, bronchitis, pneumonia, and other lower respiratory tract illnesses.
Design and Wearability
The wearable form factor allows for real-time data capture during normal daily activities or sleep. The device incorporates electronic stethoscope technology with advanced acoustic sensors capable of capturing high-quality lung sounds.
Technology and Functionality
The AeviceMD uses embedded signal processing algorithms and AI to analyze respiratory sounds, distinguishing normal from abnormal lung sounds automatically. It records and stores lung sound data for later review or transmits it wirelessly to clinical software or mobile applications for monitoring.
Clinical Workflow Integration
AeviceMD integrates with healthcare providers’ workflows via digital platforms or cloud services, facilitating remote patient monitoring and telehealth applications. The device supports alerts and notifications for abnormal sound detection, enabling timely intervention.
Regulatory Status
The device received FDA 510(k) clearance, indicating it is substantially equivalent in safety and effectiveness to legally marketed predicate devices. FDA clearance specifically includes the pediatric user group.
Benefits
The AeviceMD extends continuous, objective lung sound monitoring outside clinical settings, helping reduce the need for frequent in-person visits and supporting timely detection of respiratory events. It assists clinicians in managing chronic respiratory diseases by providing longitudinal data.
Expansion Plans
Following this pediatric clearance, Aevice Health plans to accelerate its commercialization efforts, with a focus on expanding enterprise partnerships and home care programs. The company successfully closed its Seed Plus round in late 2024, led by Coronet Ventures, the U.S. venture arm of Cedars-Sinai Intellectual Property.
Current Deployment
The AeviceMD is currently deployed across leading hospitals in the U.S. and Singapore, functioning 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 this FDA clearance extends their reach to one of the most vulnerable patient groups - young children. The AeviceMD's mission is to deliver continuous, home-based respiratory monitoring for vulnerable populations, including young children with asthma and other chronic respiratory conditions.
In summary, AeviceMD is a specialized wearable smart stethoscope cleared by the FDA for pediatric use, offering continuous respiratory sound monitoring through advanced acoustic sensing and AI analysis to support diagnosis and management of pediatric respiratory conditions.
- The AeviceMD, a game-changer in medical devices, is a wearable smart stethoscope designed for continuous lung sound monitoring in pediatric patients – a breakthrough in the healthcare industry that intersects technology and science.
- The innovative technology used in AeviceMD, such as embedded signal processing algorithms, AI, and advanced acoustic sensors, falls under the broader scope of digital health, representing a significant leap in health-and-wellness technology.
- With the clear FDA 510(k) clearance and successful fundraising, Aevice Health aims to expand its enterprise partnerships and home care programs, extending the reach of this medical-condition-focused technology to vulnerable populations and improving the finance infrastructure of medical plastics for further advancements in the healthcare sector.
