CardiacSense Watch gets CE Approval for continuous monitoring of Afib and HRV

CardiacSense Watch

Israel-based CardiacSense, a digital health company, received CE approval for its Cardiac Sense Watch.

The medical-grade watch can detect and remotely monitor Atrial Fibrillation and Heart Rate Variability( HRV).

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

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The company has also launched clinical trials to receive regulatory certification for additional vital signs, including respiratory rate, core temperature, oxygen saturation, blood pressure, and other arrhythmias.

The Arrhythmia detection market opportunity represents a multi-billion-dollar business opportunity. 

The watch can continuously detect Atrial Fibrillation, in the future additional heart arrhythmia such as Tachycardia, Bradycardia, PVCs. PACs, Long QTs, Pause, and Cardiac Arrest detection will be added.CardiacSense Watch Blood Pressure

Blood Pressure Monitoring with CardiacSense Watch 

The watch also uses PPG to help with blood pressure monitoring. The high-quality HRV reading and body temperature monitoring can be used for stress detection, Sleep Apnea, and other use cases.

The CardiacSense watch facilities remote monitoring. Your physician will get a real-time notification once the watch detects a problem. On top of that, the physician has access to all the raw data stored in the cloud application.

The company also markets a wristband called the Clip that can monitor blood pressure and continuous SpO2, among other things.CardiacSense Wearable devices

CardiacSense has also developed its monitoring technology as a SOM (System on module). This means that other OEM’s can leverage the chip and include it on their own devices once the company receives regulatory approval.

CardiacSense has signed $100 million distribution agreements in 16 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 the acute care setting and home monitoring of chronic disease patients both of which represent additional multi-billion-dollar business opportunities for the company.

The company will start selling the CardiacSense watch in the US once it receives FDA clearance in a few months.

As established wearable players such as Apple and Samsung take steps to improve their watches’ health and remote monitoring capabilities, new companies such as CardiacSense are innovating at high speed and seeking regulatory approvals to become a viable payer in the medical-grade wearables space.

Source: CardiacSense Watch

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Sudz Niel Kar
I am a technologist with years of experience with Apple and wearOS products, have a BS in Computer Science and an MBA specializing in emerging tech, and owned the popular site AppleToolBox. In my day job, I advise Fortune 500 companies with their digital transformation strategies and also consult with numerous digital health startups in an advisory capacity. I'm VERY interested in exploring the digital health and fitness-tech evolution and keeping a close eye on patents, FDA approvals, strategic partnerships, and developments happening in the wearables and digital health sector. When I'm not writing or presenting, I run with my Apple Watch Ultra or Samsung Galaxy Watch and closely monitor my HRV and other recovery metrics.


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