CardiacSense 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 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.
Eldad Shemesh, CardiacSense Founder and CEO commented that “Motion artifacts are the key problem plaguing other PPG based systems. We have developed proprietary hardware, including a novel motion artifact sensor, which identify and cancel out motion artifacts thereby leaving us with a pure biometric signal for accurate vital sign monitoring. Clinical data submitted to the FDA demonstrated sensitivity and specificity of 99.6% for beat-by-beat heart rate when compared to Holter Monitor.”
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.
Samuel Viskin MD, Senior Electrophysiologist at Tel Aviv Medical Center, Israel and advisor to CardiacSense commented “the CSF-3 medical grade vital sign monitor from CardiacSense has the potential to dramatically improve the care we provide to patients with Cardiac Arrythmias like Atrial Fibrillation, as well as patients with chronic conditions like Heart Failure and COPD.”