Israeli digital health company CardiacSense has received US FDA clearance for its CSF-3 watch to measure beat-by-beat heart rate and oxygen saturation of arterial haemoglobin (SpO₂).

The company makes medically certified wearable devices for monitoring vital signs.

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 commercialisation 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 US commercial partners and expects to finalise agreements and launch in the USA in the second half of 2023.

“Motion artifacts are the key problem plaguing other PPG based systems,” said Eldad Shemesh, CardiacSense CEO. “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, actual and variability respiratory rate, and blood pressure. The company will be submitting these data for FDA review over the course of 2023.

Early last year, the company submitted data for CE review for respiratory rate and oxygen saturation monitoring. With approval of these indications, CardiacSense says it will become the company with the largest number of regulatory-approved medical indications for a wearable device.

Samuel Viskin, senior electrophysiologist at Tel Aviv Medical Center and advisor to CardiacSense, said: “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.”