AsiaNet 88036

CAESAREA, Israel, Feb. 10,2021/PRNewswire＝KYODO JBN/--

- The watch will begin shipping in EU as a medical device for continuous

measurement of heart rate and arrhythmias at ECG-level accuracy

    CardiacSense [http://www.cardiacsense.com/] -  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

[https://www.youtube.com/watch?v=U4FzoHCS12E&feature=emb_logo] 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 [http://www.cardiacsense.com/] 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 [https://www.youtube.com/watch?v=U4FzoHCS12E&feature=emb_logo]

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. www.cardiacsense.com

   Further information:

   Eyal Copitt, CCO

   eyal@cardiacsense.com