Biobeat’s Wearable Blood Pressure Monitors Receive FDA 501K Clearance

Biobeat blood pressure monitor

Biobeat, an Israeli bio-medical technology company received FDA 501K clearance for its patch and smartwatch for measurement of blood pressure, oxygenation and heart rate in hospitals, clinics, and at home. Biobeat is a winner of the IOT/WT Innovation World Cup® (Gore Innovation Center Prize) and speaker and exhibitor of the WT | Wearable Technologies Conference Series.

“This is the first cuffless blood pressure solution to be cleared by the FDA—no more need for an inflating cuff,” says Arik Ben Ishay, Founder and CEO of 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 US market,” continues Ben Ishay. Biobeat’s products have already been CE marked and approved as medical devices in Europe and Israel.

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The smartwatch can be worn for three days before needing a charge, while the patch is designed for use of up to 10 days. The company says the patch can provide the same vital signs as the watch.

Blood pressure monitoring app
Image: Biobeat

“Remote monitoring of patient’s vital sign requires completely different technological approaches than current practice,” says Biobeat’s Chief Medical Officer Prof. Arik Eisenkraft, MD. “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,” continues Prof. Eisenkraft.

Dr. Dan J. Gelvan, Chairman of the Board said:

“The promise of remote care for patients and the equally important continuum of care: connecting home-based, community and hospital care, will not happen without novel medical-grade sensors and we are proud to be the pioneers in this field.”

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Founded in 2016, Biobeat aims to create wireless medical-grade products that allow health providers to care as efficiently for patients outside of their facility as on-site. Its products enable cloud-based healthcare with connectivity through a smartphone or dedicated a gateway. Biobeat’s sensors are based on the company’s exceptional proprietary technologies in the field of reflective Plethysmography (PPG), developed by a team of world-renowned experts in this field.