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.
"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.