FDA clears 'cuffless' blood pressure tracking smartwatch from Biobeat

FDA
The company said its products are designed for long-term use in hospitals, clinics and the home. (Andrew Harnik, Associated Press)

Biobeat has received clearance from the FDA for its smartwatch-based patient monitoring device, designed to track a user’s blood pressure and other vital signs without the use of the traditional inflated cuff.

Given the OK alongside a similar 10-day patch worn on the upper torso, the devices’ optical sensors employ light to noninvasively measure changes in the skin, including pulse rate and oxygenation comparable to other devices.

The company said its products are designed for long-term use in hospitals, clinics and the home. Compared to the watch, the patch also includes a single-lead ECG.

Webinar

CIOs’ Perspectives: Driving Clinical Trial Innovation with a Unified Platform

IT is being challenged with either trying to fix and maintain an already complex system of solution integrations, or exploring driving business impact by unifying its systems under one platform. Attend and learn about the IT benefits to shifting resources away from disparate systems and moving towards a unified platform.
Biobeat's watch and patch. (Image: Biobeat)

"This clearance opens tremendous opportunities for remote monitoring of vital signs of patients and we are excited that we can now also offer this in the U.S. market," Biobeat founder and CEO Arik Ben Ishay said in a statement. The Tel Aviv-based Biobeat's has previously received CE marks and approvals in Europe and Israel.

The products can upload their data to a cloud-based server via the person’s smartphone or through dedicated hardware within the clinic, the company said.

"Remote monitoring of patient's vital sign requires completely different technological approaches than current practice," said Chief Medical Officer Arik Eisenkraft.

"While blood pressure, heart rate and oxygenation are the backbones of monitoring, we will continue to work with the FDA to approve additional parameters for our devices," Eisenkraft said, which may include measurements of cardiac output, respiratory rate and sweat levels according to Biobeat.

Suggested Articles

Researchers are studying the retrovirus KoRV-A, which is spreading among koalas, to gain new insights into how DNA evolves.

The FDA approved its first rapid in vitro diagnostic for confirming Ebola virus infections with potential results in about a half-hour.

Shionogi and Hsiri Therapeutics first joined forces last year in a licensing and R&D deal focused on tuberculosis and non-tuberculous lung infections.