CardiacSense has received the CE mark to market and sell a medical grade watch which can detect and remotely monitor atrial fibrillation (AF) and heart rate variability (HRV). The indications certified include detection of AF and monitoring of HRV with continuous photoplethysmography (PPG) and spot electrocardiogram (ECG).
CardiacSense’s medical watch CE mark enables continuous, long-term, accurate and comfortable patient monitoring without the need to implant invasive cardiac monitors—a prevalent practice for patients experiencing arrhythmias, the company said in a press release. Data from two clinical trials reviewed for the CE mark demonstrated accurate detection of AF by continuous PPG of over 99%.
The certification will enable commercialisation of the device in the EU and other CE mark approved countries. In parallel, 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.
“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 heart beat level and arrhythmias detection, a milestone that will enable us to implement the distribution agreements we have signed in 15 countries,” announced Eldad Shemesh, co-founder and CEO of CardiacSense. “We anticipate additional commercial agreements and partnerships over the coming months and our watch has been submitted for [US Food and Drug Administration] 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.”