CardiacSense – a digital health company that developed and clinically verified a medical grade watch capable of detecting and remotely monitoring Atrial Fibrillation (A-Fib) and Heart Rate Variability (HRV) – has received the CE Mark for marketing and sales of the device in the European Union.
CardiacSense medical grade watch receives CE Mark for continuous detection of atrial fibrillation
The indications certified include ‘detection of Atrial Fibrillation (A-Fib)’ and ‘monitoring of Heart Rate Variability (HRV)’ with continuous Photoplethysmography (PPG) and spot Electrocardiogram (ECG).
Data from two clinical trials reviewed for the CE Mark demonstrated accurate detection of A-Fib by continuous PPG of over 99 per cent.
The company has launched clinical trials to receive regulatory certification for additional vital signs including continuous respiratory rate, core temperature, oxygen saturation, blood pressure, and other arrhythmias.
CEO and Co-Founder Eldad Shemesh said: “CardiacSense is the first and only company to receive CE Mark certification for continuous PPG wrist-based monitoring at the individual heart beat level and arrhythmias detection, a milestone that will enable us to implement the distribution agreements we have signed in 15 countries. We anticipate additional commercial agreements and partnerships over the coming months as well as completing the 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.”
The Arrhythmia detection market opportunity represents a multi-billion-dollar business opportunity. CardiacSense has signed $100m (~€81m) distribution agreements in 16 countries and is developing its commercial strategy in the US, China, Japan, and Europe.