![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » FDA Clears NimbleHeart’s Reusable ECG Device
FDA Clears NimbleHeart’s Reusable ECG Device
![FDA_Logo_Black_2016.gif](https://www.fdanews.com/ext/resources/test/Drug-Images4/FDA_Logo_Black_2016.gif?t=1579040596&width=430)
NimbleHeart’s reusable ECG device, the Physiotrace Smart, has received FDA marketing clearance. The device wraps around a user’s torso, and is used without electrolytic gels or adhesives.
The device’s dry electrode technology makes it easier to clean and avoids the discomfort of patch- or strap-based ECG devices.
Physiotrace Smart is designed for independent home use. The mobile app displays the status of the device, the user’s heart rate, and ECG waveform during a recording session. The app also collects and manages data sent by the device, which it uploads to a cloud service for storage and caregiver review.
Upcoming Events
-
21Oct