A Tel Aviv, Israel-based company is taking blood pressure monitoring cuff-less with its latest device. Biobeats has developed and received FDA clearance for a wearable medical-grade product that would allow health providers to care as efficiently for patients outside of their facility as on-site.
“We’re the first company to receive FDA clearance for the optical measurement of blood pressure,” Arik Eisenkraft, MD, MHA, and CMO of Biobeats, told MD+DI. “This is a cuff-less device. We have two configurations either a wristwatch or a patch.”
Biobeat's sensors are based on Plethysmography (PPG) technology. The company said its products feature a cloud connectivity capability that allows second parties and physicians to gauge results remotely either through a smartphone or dedicated gateway.
Eisenkraft made it very clear that the device wasn’t another wellness technology and that it was a medical-grade offering. The technology has a much broader indication in Europe.
“We gather about 20 different vital signs,” Eisenkraft said. “All of them have already been approved [in Europe]. But we’re also seeking FDA clearance for these vital signs. [In the U.S.] we have clearance for blood pressure; pulse rate; and oxygen saturation. These vital signs are regarded as the main cornerstones of monitoring.”
Eisenkraft said the company will continue to work with FDA to approve additional parameters for its devices.