CardiacSense Earns FDA Nod for CSF-3 Medical Watch

CardiacSense, an Israeli digital health firm, has earned U.S. Food and Drug Administration (FDA) clearance for its CSF-3 watch to measure beat-by-beat heart rate and oxygen saturation of arterial hemoglobin.
 
The CSF-3 watch received CE marks for four indication, including continuous atrial fibrillation (AF) monitoring and beat-by-beat pulse rate using photo-plethysmography (PPG). The company also commercialized the medical-grade CSF-3 watch in a dozen countries across Europe, Asia, and South America.
 
CardiacSense plans to submit further data to the FDA to support approval of additional indications. The company is in discussions with potential U.S. commercial partners and aims to finalize agreements and launch in the U.S. in the second half of 2023.
 
Eldad Shemesh, CardiacSense founder and CEO told the press 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.”
 
CardiacSense has conducted clinical trials showing medical-grade accuracy for the CSF-3 optical sensors to monitor cardiac AF, respiratory rate, and blood pressure. This data will be submitted to the FDA over the course of the year.
 
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.”