Ltd., a digital health company that developed the world’s most advanced, medically certified wearable device for monitoring vital signs announced receipt of U.S.A. Food and Drug Administration (FDA) clearance of its CSF-3 watch for measuring Electrocardiogram (ECG), Beat-by-beat Heart Rate, and Oxygen Saturation of Arterial Hemoglobin (SpO2). The CSF-3 watch has already received CE approval from the Europe Medical Device Regulation (MDR) for four indications including continuous monitoring of Atrial Fibrillation (AF). and beat-by-beat pulse rate by photo-plethysmography (PPG) which are unique CE regulatory approvals. Leveraging the CE mark, CardiacSense has begun commercialization of the medical grade CSF-3 watch in a dozen countries across Europe, Asia and South America. During 2023, the company plans to submit additional data to the FDA, much of which has already been generated, to support approval of additional indications. The company is in discussions with prospective USA commercial partners and expects to finalize agreements and launch in the US market in the second half of 2023. References Health care companies of Israel Health care companies established in 2009 Medical device manufacturers Israeli brands 2009 establishments in Israel