FDA Clears NimbleHeart’s Reusable ECG Device

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.