FDA clears app-driven, easy-to-clean ECG device

By Dave Muoio
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NimbleHeart, the Campell, California-based producer of clinical-grade mobile cardiac monitoring devices, announced that its fully reusable ECG device has received FDA clearance and will soon be brought to market.

The Physiotrace Smart wraps around a users torso, and is used without electrolytic gels or adhesives. It can be cleaned and disinfected easily by wiping with water and alcohol, thereby making it ideal for multi-patient use. These features, enabled by the device’s dry electrode technology, allow NimbleHeart’s device to avoid the more complicated cleaning requirements and discomfort of other patch- or strap-based ECG devices.

Physiotrace Smart is also designed for home use. It’s controlled by a mobile app, which 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 will upload to a cloud service for storage and caregiver review.

“The whole value is for the scenarios that need ECG monitoring for long term,” Cofounder and CEO Sonal Tambe told MobiHealthNews, “not just once for 24 hours for a diagnosis, but more often for monitoring the patients with known cardiac risk.”

As per NimbleHeart’s marketing material for the Physiotrace Smart, the device can be worn inside a users regular clothing, and due to its avoidance of adhesives is more convenient for users with body hair. Physiotrace Smart does not require a nurse or other caregiver to assist the patient, and eliminates the need to stock and reorder disposable and fragile electrodes.

NimbleHeart says that it will soon be bringing Physiotrace Smart to market in the US, as well as in other markets that accept FDA regulation.

Among the ECG devices the Physiotrace Smart would seek to replace are iRhythm's Zio patch and Vital Connect's VitalPatch, both of which are adhesive-reliant. iRhythm filed with the SEC to raise up to $86 million in an initial public offering last year, while Vital Connect collected $10.6 million in funding for its disposable monitors around the same time.

NimbleHeart’s pitch of user accessibility and easy home use will also face stiff competition from AliveCor's smartphone-based device, which only requires the user to touch their fingertips to a sensor. Earlier this year, the company announced a partnership with the Mayo Clinic to develop algorithms to screen for Long QT syndrome, and more recently demonstrated its ability to detect atrial fibrillation in a series of studies.