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Medical Devices / Submissions and Approvals

FDA Clears Biobeat’s Cuffless Blood Pressure Monitors

Aug. 27, 2019
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The FDA granted Biobeat 510(k) clearance for its blood pressure, oxygenation and heart rate patch and watch monitors.

The devices take away the need for an inflating cuff, enabling remote monitoring and cloud-based healthcare, with data transmitted using either WiFi, Bluetooth, radiofrequency or a smartphone.

The products are the first of their kind to receive FDA clearance, the company said. They previously gained the CE Mark.

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