Biobeat’s Patch-Watch Vital Sign Wearables Earn Widened FDA Approval

Medtech company Biobeat has grown its reputation by bringing a number of unique AI-centric health capabilities to the competitive patient monitoring space. Now, with a broadened FDA greenlight for its smartwatch and chest patch combo, the Israel-based startup is poised to outpace high-profile sector rivals such as Fitbit and Apple. Biobeat hit the ground running in 2019, with the distinction of its aforementioned devices being the first to earn FDA clearance for sensor-only blood pressure measurement—without the need for an inflatable cuff. Today, competitors in the sector have yet to add the same feature to their devices, while Biobeat’s newly expanded FDA nod includes body temperature and respiratory rate tracking.

In Europe, the company’s entire portfolio of vital sign-monitoring abilities has scored CE-mark approval. May 2021 saw the addition of tracking for pulse pressure, stroke volume, mean arterial pressure, pulse rate variability, systemic vascular resistance, cardiac output, and cardiac index, for a total of 13 parameters. That same month, the company introduced its wearables to the U.S. market. The initial rollout catered to healthcare providers, but eight months later, a single-use edition of the chest patch was made available direct-to-consumer.

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