Empatica’s EmbracePlus Smartwatch receives CE approval as a Class IIa medical device

Empatica Embraceplus

Empatica’s EmbracePlus, the only medically certified smartwatch, received the European CE approval as a Class IIa medical device.

The EmbracePlus is a medical-grade smartwatch that helps with continuous monitoring of numerous physiological signals that include the pulse rate, pulse rate variability, blood oxygenation, respiratory rate, skin temperature, electrodermal activity, rest, and actigraphy data.

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EmbracePlus also enables the development and monitoring of digital biomarkers, the output of data reprocessed by algorithms.

The watch is also equipped with integrated PRO functionality making it a great choice for your clinical trials.

It supports direct integration of patient-reported outcomes, collecting questionnaires and notifications through watch input.

EmbracePlus also comes complete with a portable on-wrist charger, guaranteeing infinite battery life. This allows for continuous, unobtrusive data collection free of interruptions.

EmbracePlus has been developed with key partners, including HHS, USAMRDC, and the NASA-funded Translational Research Institute for Space Health. It is currently being rolled out for use with select clinical partners and will not be directly available to consumers.

Empatica CTO Simone Tognetti stated: “The EmbracePlus is the result of years of hard work from our team, culminating in a medical device that offers the best of Empatica’s technology, used in over 1,000 published papers: a compact and comfortable design with powerful sensors. We believe it will help in delivering our vision, to help millions of patients with new insights about their health and ultimately better care.”

Empatica’s smartwatches have been used in several studies, including Stanford University, to help study the early detection of respiratory infections.

The company’s Aura product recently won CE approval for use in the early detection of COVID-19.

Empatica’s research goes back to 2007 on a project led by Prof. Rosalind Picard, now Empatica’s chief scientist, at the MIT Media Lab.

Picard, who also co-founded Affectiva (a local company focusing on Emotion AI that raised more than $26 million), developed consumer-friendly wearables as part of a previous venture, Physiio International Inc. 

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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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