Heart Monitoring Smartwatch Receives FDA Approval

A smartwatch that provides advanced monitoring of vital signs for heart patients has just received FDA clearance. 

CardiacSense has received European approval for four advanced measurements, including irregular heart beats, and detecting blood volume changes as a means of measuring heart rate.

It has already started selling its medical grade CSF-3 watch in a dozen countries across Europe, Asia, and South America.  

The FDA has given its approval for its oxygen saturation measurements, and heart rate measurement. And during 2023, the company plans to submit additional data to the FDA to gain approval for more measurements. 

CardiacSense is in discussion with commercial partners in the US, and expects to launch its product in the second half of 2023. 

“Motion artifacts (when patient movements cause blurring in scans) are the key problem plaguing other PPG based systems (using blood volume changes to measure heart rate),” said Eldad Shemesh, CardiacSense Founder and CEO.

“We have developed proprietary hardware, including a novel motion artifact sensor, which identifies and cancels 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 (a standard heart monitor that records activity over 24 hours).”

CardiacSense was founded in 2009, and is based in Caesarea, north-central Israel.