Digital health company CardiacSense has secured CE mark approval for its medical-grade watch for continuous detection of atrial fibrillation.
The company will start supplying the watch in the European Union (EU) region and other CE mark accepting countries as a medical device for continuous measurement of heart rate and arrhythmias at electrocardiogram (ECG) level accuracy.
The indications approved comprise detection of atrial fibrillation (A-Fib) and monitoring of heart rate variability (HRV) with continuous photoplethysmography (PPG) and spot ECG.
CardiacSense’s medical watch is designed to facilitate continuous, long-term, precise and comfortable patient monitoring without using invasive cardiac monitors.
The medical watch incorporates advanced patent-protected sensors and software algorithms to deliver continuous measurement of parameters such as core temperature, respiratory rate, blood pressure, oxygen saturation and heart rate at CE and FDA-mandated accuracies
CardiacSense stated that the data from two clinical studies showed precise detection of A-Fib by continuous PPG of more than 99%.
CardiacSense co-founder and CEO Eldad Shemesh said: “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.
“We anticipate additional commercial agreements and partnerships over the coming months and our watch has been submitted for FDA clearance.”
In addition, the firm is conducting clinical studies to secure regulatory certification for additional vital signs such as continuous respiratory rate, core temperature, oxygen saturation, blood pressure, and other arrhythmias.
CardiacSense has entered into $70m distribution agreements for its technology in 15 countries.
In addition, the company is working on a commercial strategy in the US, China, Japan, and major European countries for the arrhythmia detection market and for continuous wrist-based vital signs monitoring in an acute care setting and home monitoring of chronic disease patients.
