By Andrea Park , Associated Press

With its initial FDA clearance in 2019, Biobeat’s wireless, app-connected smartwatch and chest patch became the first devices cleared to measure blood pressure without the use of an inflatable cuff.

Though major tech developers like Apple and Google-owned Fitbit have taken center stage in the race to infuse wearable technology with as many health-tracking capabilities as possible, a small startup out of Israel has quietly lapped them all.

Back in 2019, Biobeat lept well ahead of the pack with FDA clearance for its smartwatch and chest patch, making them the first devices cleared to measure blood pressure using only sensors, without requiring an inflatable cuff. Its competitors are scrambling to this day to add blood pressure monitoring to their own wireless wearables.

With the clinical and over-the-counter rollout of Biobeat’s system well underway, the company is now doubling back to add even more features to its remote health monitoring devices. This week, the company announced that the FDA has greenlit respiratory rate and body temperature tracking.

“With a total of five vital signs cleared by the FDA, including cuffless blood pressure, blood oxygen saturation, pulse rate, respiratory rate and body temperature, we are confident that our remote patient monitoring solution is a superior solution for the US healthcare market, and we are excited to expand our operation and continue providing care teams with an accurate and reliable patient monitoring system,” said CEO Arik Ben Ishay.

FDA clears ‘cuffless’ blood pressure tracking smartwatch from Biobeat

Biobeat’s system includes the wrist-worn smartwatch and an adhesive patch that can be attached anywhere on the upper torso. Each device offers battery life of up to five days, and while the smartwatch is meant to be recharged and worn over long periods of time, the patch—which also features a single-lead ECG—is disposable and designated only for short-term use.

Both devices wirelessly connect to the Biobeat app on a user’s smartphone to send their health-tracking data to the cloud. There, Biobeat’s artificial intelligence algorithms analyze the vital sign information that the devices collect, and reports are compiled that can be shared with healthcare providers.

With their initial clearance in October 2019, the devices were okayed in the U.S. to measure blood pressure, oxygenation and heart rate.

Meanwhile, in Europe, Biobeat has already secured CE mark approval for its entire slate of vital sign monitoring abilities. In May 2021, it was cleared on the continent to track a total of 13 parameters, adding pulse rate variability, mean arterial pressure, pulse pressure, stroke volume, cardiac output, cardiac index and systemic vascular resistance to its offerings.

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In the US, Biobeat began rolling out its wearable devices in May 2021. Though the launch originally targeted only healthcare providers, by October, the company had begun offering a single-use version of the chest patch directly to consumers.

The “24BP” kit is available for purchase through Biobeat’s website for US$99. It’s meant to be worn for just 24 hours before disposal. After the wear period, the corresponding smartphone app delivers a report analyzing the patient’s 24 hours’ worth of blood pressure patterns, suggesting how their blood pressure changes throughout their daily activities.