CardiacSense today said it received CE mark approval for its medical-grade watch that remotely and continuously monitors atrial fibrillation and heart rate variability.
The watch was approved for Afib detection and heart rate variability with continuous Photoplethysmography (PPG) and electrocardiogram (ECG). It allows for continuous, long-term, accurate and comfortable patient monitoring without the need to implant invasive cardiac monitors.
Data from two clinical trials of the watch demonstrated accurate detection of Afib by continuous PPG of over 99%.
“Following an extensive development process and clinical trials, CardiacSense is the first and only company to receive CE Mark certification for continuous PPG wrist-based monitoring at the individual heartbeat level and arrhythmias detection, a milestone that will enable us to implement the distribution agreements we have signed in 15 countries,” cofounder and CEO Eldad Shemesh said in a news release. “We anticipate additional commercial agreements and partnerships over the coming months and our watch has been submitted for FDA Clearance. Our watch was developed by integrating sophisticated proprietary electro-mechano-optical sensors and advanced software algorithms, providing physicians with precise, long-term, remote monitoring of medical parameters wherever their patients may be situated.”
CardiacSense plans to commercialize the medical watch in the EU and other CE mark approved companies. The company said it has also launched clinical trials to receive regulatory certification for additional vital signs, such as continuous respiratory rate, core temperature, oxygen saturation, blood pressure and other arrhythmias.