AeviceMD
Aevice Health Pte. Ltd.AeviceMD is a wearable, non-invasive electronic stethoscope that records lung sounds from pediatric patients. It stores these sound recordings securely on a cloud platform, allowing healthcare professionals to later review, compare, and analyze them to support clinical assessments. The system includes hardware sensors, docking station, mobile and web apps, and cloud analytics to facilitate longitudinal monitoring of lung sound data.
Intended Use
The AeviceMD is a non-invasive battery-operated device, including a wearable component, intended to longitudinally acquire, record and store lung sounds from pediatric patients (aged 3 years and above) in a clinical or non-clinical setting. The device stores the data for later playback, review, and analysis by a clinician and comparison with earlier data from the same patient.
Technology
AeviceMD consists of a wearable electronic sensor to detect and record lung sounds, a silicone patch to attach to the chest, a docking station for data transfer and charging, mobile and web applications for data access, and a cloud platform for secure data storage and analysis. The device transmits lung sound data via Bluetooth to a gateway and supports playback and clinician review.
Performance
Non-clinical performance testing included biological evaluation (cytotoxicity, skin sensitization), electrical safety and electromagnetic compatibility, usability testing, frequency response and stethoscope performance testing against predicate devices, human factors, shipping and cleaning validation tests. Results demonstrated the device is safe, effective, and substantially equivalent to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/21/2024
5 months - 2
FDA Approval
5/5/2025
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