Empatica achieves the CE mark for its medical smartwatch

EmbracePlus, a medical smartwatch by, Empatica receives the European CE mark as a Class lla medical device for its ability to consistently provide quality physiological parameters to users. 


These data are continuously sent to a smartphone app and transferred to the cloud for review and analysis by clinical researchers and healthcare professionals through a single portal. The data can be viewed simultaneously from thousands of devices via Empatica software and third-party applications developed using Empatica’s SDK.


Boasting Empatica’s proprietary PPG and EDA sensors, EmbracePlus is the only medically certified smartwatch that enables continuous vital signs monitoring alongside continuous EDA monitoring, an important metric in the field of neurology and psychiatry research. 


The combination, quality, and scale of data collected remotely by EmbracePlus can enable the creation of novel digital endpoints, allowing clinical trials to become patient-centric while uncovering new insights.


Simone Tognetti, CTO, Empatica, 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.”


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