Country for PR: United Kingdom
Contributor: PR Newswire Europe
Wednesday, February 10 2021 - 19:16
CardiacSense Medical Grade Watch receives CE Mark for continuous detection of Atrial Fibrillation
CAESAREA, Israel, Feb. 10,2021/PRNewswire-AsiaNet/--

- The watch will begin shipping in EU as a medical device for continuous 
measurement of heart rate and arrhythmias at ECG-level accuracy

    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) announced that it received the CE Mark for marketing & sales 
of the device in the European Union. 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).

    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.  Data from 2 clinical trials reviewed for the CE Mark 
demonstrated accurate detection of A-Fib by continuous PPG of over 99%.  

    The certification will enable commercialize of the medical watch 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 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 $70 million 
distribution agreements in 15 countries and is developing its commercial 
strategy in the USA, China, Japan, and major countries in Europe for both the 
arrhythmia detection market and for continuous, comfortable, wrist based, 
accurate vital signs monitoring in acute care setting and home monitoring of 
chronic disease patients both of which represent additional 
multi-billion-dollar business opportunities for the company. 

    About CardiacSense

    CardiacSense [] is a digital health company 
that has developed CE approved best-in class, wrist-wearable sensor technology 
with the sensitivity and specificity required for medical diagnosis and 
monitoring of vital signs, arrhythmias, and chronic disease deterioration. The 
medical watch [] 
integrates proprietary patent-protected sensors and software algorithms to 
provide continuous measurement of parameters such as core temperature, 
respiratory rate, blood pressure, oxygen saturation and heart rate at CE and 
FDA-mandated accuracies – providing an alternative to costly, complex and 
invasive devices. This addresses the increasing global demand for remote 
patient monitoring and tele-health. CardiacSense was founded in 2009 and is 
headquartered at Caesarea, Israel.

   Further information:
   Eyal Copitt, CCO