CardiacSense, a digital health company that developed a medically certified wearable device for monitoring vital signs, announced receipt of FDA clearance of its CSF-3 watch for measuring 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.
The company has conducted clinical trials demonstrating medical grade accuracy of the CSF-3 optical sensors for monitoring Cardiac Arrhythmias, Respiratory Rate (actual & variability), as well as Blood Pressure. The company will be submitting these data for FDA review over the course of 2023. In Q1 2022 the company submitted data for CE review for Respiratory Rate and Oxygen Saturation monitoring. With approval of these indications, CardiacSense will become the company with the largest number of regulatory-approved medical indications for a wearable device.