Biobeat Receives CE Mark for its Patch and Wristwatch for Vital Signs Monitoring

Biobeat Receives CE Mark
Image: PRNewswire

Biobeat, a bio-medical technology company developing advanced sensing and remote monitoring solutions for patients, received CE Mark approval for its patch and wristwatch for measurement of blood pressure, cardiac output, stroke volume, blood oxygenation and heart rate in hospitals, clinics, long-term care and at home. Biobeat’s products enable cloud-based healthcare with connectivity either through a smartphone or a dedicated gateway.

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Biobeat’s devices use a proprietary PPG sensor to obtain a very clear reading of the PPG signal wave, allowing them to measure a wide range of vital signs.

“This is the first PPG-based non-invasive cuffless blood pressure solution to receive CE Mark approval,” says Arik Ben Ishay, Founder and CEO of Biobeat. “This clearance enables tremendous opportunities for remote medical grade monitoring of patients, and we are excited that we can now offer this in the EU market,”

In August, 2019, Biobeat received FDA 501(k) approval for its blood pressure monitor.

The Biobeat smartwatch and patch connect to the cloud through either a smartphone or a dedicated gateway. Each device is intended for use in different use cases, where the user must wear only one of the two devices. The watch is to be worn on the wrist while the patch is to be placed anywhere on the upper torso, says a press release.

A person checking his smartwatch
The Biobeat smartwatch continuously measures parameters which are defined and set by the user, broadcasting them to the app in real-time (Image: Biobeat)

“Remote monitoring of a patient’s vital signs 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 can now also provide measurements of stroke volume and cardiac output, and we will continue working to approve additional parameters for our devices,” continues Prof. Eisenkraft.

“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,” says Dr. Dan J. Gelvan, Chairman of the Board.

Israel-based Biobeat has 15 employees and the company has initiated sales in Israel and Europe. Biobeat is focusing on wireless medical-grade products that allow health providers to care as efficiently for patients outside of their facility as on-site.