FDA Approves First Cuffless Blood Pressure Monitoring Devices

The US Food and Drug Administration (FDA) has granted 510(k) clearance to the first non-invasive cuffless blood pressure-monitoring wearable watch and patch device.

The smartwatch and patch products from biomedical technology company Biobeat provides measurement of blood pressure, oxygenation, and heart rates in both clinical inpatient and outpatient settings. Though it could be available in hospital and primary care settings, users would be able to monitor their vitals at home as well.

The Biobeat products also feature a cloud connectivity capability which allows second parties and physicians to gauge results remotely either through a smartphone or dedicated gateway. Both devices are capable of the same monitoring offerings and are not intended to be used together.

While the watch is required to be worn on users’ wrists, the patch can be placed anywhere on the upper torso.

Arik Ben Ishay, founder and chief executive officer of Biobeat, observed the clearance indicates no need for inflating cuff blood pressure monitor tests in the US.

“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 US market," Ben Ishay said in a statement.

Chief Medical Officer Arik Eisenkraft, MD, expressed excitement for the devices’ clearance in blood pressure, heart, and oxygenation monitoring—the “backbones of monitoring,” he noted. That said, there is more work to be done with the FDA to achieve additional monitoring parameters for both the watch and patch.

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