CardiacSense wins FDA clearance for medical-grade watch

The CSF-3 medical-grade watch. [Image from CardiacSense website]CardiacSense announced today that it received FDA clearance for its CSF-3 watch for measuring a handful of vital signs.

The watch measures beat-by-beat heart rate and oxygen saturation of arterial hemoglobin (SpO2). Caesarea, Isreal-based CardiacSense received CE mark approval for four indications for the watch in February 2021. That approval included continuous AFib monitoring and beat-by-beat pulse rate by photo-plethysmography (PPG).

CardiacSense said it plans to submit additional data to the FDA to support additional indications. It’s engaged in discussions with prospective U.S.-based commercial partners. The company expects to finalize agreements and launch CSF-3 in the U.S. in the second half of 2023.

The company conducted clinical trials demonstrating the accuracy of CSF-3’s optical sensors. They monitor cardiac arrhythmias, respiratory rate and blood pressure. CardiacSense p…

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