The U.S. Food and Drug Administration (FDA) has granted a 501K clearance for Biobeat’s patch and watch for measuring blood pressure, oxygenation and heart rate in hospitals, clinics, long-term care facilities and at home.
This is the first time the FDA has given the green light for a non-invasive cuffless blood pressure-monitoring wearable watch and patch.
The FDA said Biobeat’s products removed the need for an inflating cuff, enabling remote monitoring and cloud-based healthcare, using data transmitted through WiFi, Bluetooth, radiofrequency or a smartphone.
Arik Ben Ishay, founder and Chief Executive Officer of the Tel Aviv based Biobeat, said the FDA’s nod opened tremendous opportunities for remote monitoring of patients’ vital signs. With the clearance, Ishay said “we are excited that we can now also offer this in the US market.”
Biobeat’s products were already cleared for sale in the European and Israeli markets, where they are approved as medical devices.
A statement said the biomedical technology company’s products allow for cloud-based healthcare with connectivity either through a smartphone or a dedicated gateway.
Remote monitoring of blood pressure is Biobeat’s unique selling point. The company’s products allow for cloud connectivity capability, permitting second parties and physicians to gauge results remotely either through a smartphone or dedicated gateway.
“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,” Dan J. Gelvan, the chairman of Biobeat’s board, said.
Biobeat’s chief medical officer, Arik Eisenkraft said remote monitoring of a patient’s vital signs required completely different technological approaches from what was currently on the market and that is what his company sought to provide.
“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.
The patch and smartwatch devices both have the same monitoring capabilities and are not meant to be used together, it was reported. The patch can be worn anywhere on a patient’s upper torso.
The Inside Digital Health website explained that Biobeat’s products feature an accelerometer, Bluetooth communication, recording memory, temperature measurement, a photoplethysmogram to detect blood volume changes), and a galvanic skin response sensor to measure the electrical conductance of the skin.
On its website, the patient monitoring start-up describes its smartwatch as the “ultimate device” for chronically ill patients for whom long term trends of vital signs are important to reduce readmission rates. The watch can be used for up to three days before needing to be recharged. The patch can be used continuously for up to 10 days.
The company also has a smartphone app that allows real-time user interface, with which users can interact and through which they can follow their vital signs, add important data such as their medications and mark the time at which they took their medication.
Biobeat’s devices use several LED sources, wavelengths, and proprietary algorithms to receive the PPG signal free of background noise. The company also provides a dedicated gateway that allows healthcare providers to access patient information through an app.
Earlier this year, the PCMag website described Biobeat’s smartwatch as one of the seven eye-catching wearables at the Mobile World Congress 19.
Biobeat joins Japanese healthcare tech firm, Omron which secured FDA clearance in 2017 for its smartwatch, HeartGuide, which monitors oscillometric blood pressure. With a heart attack occurring every 40 seconds, advocates for blood pressure monitoring say such devices can do wonders for over 40 million Americans with uncontrolled hypertension.