Empaticas EmbracePlus receives CE mark for high quality physiological data acquisition

BOSTON, March XNUMX / PRNewswire / - A medical smartwatch for researchers and healthcare providers to continuously and objectively collect data from patients while enabling large-scale health monitoring

EmbracePlus from Empatica has received the European CE mark as a class lla medical product for its ability to provide the user with consistently high quality physiological parameters. EmbracePlus is a medical smartwatch that continuously and remotely collects and processes physiological signals from the wrist, including pulse rate, pulse rate variability, blood oxygen levels, respiratory rate, skin temperature, electrodermal activity, rest, and actigraphy data.

This data is continuously sent to a smartphone app and transferred to the cloud through a single portal for review and analysis by clinical researchers and healthcare professionals. Data can be streamed from thousands of devices simultaneously. This can be done using both Empatica software and third-party applications that can be developed using Empatica's SDK.

Equipped with Empatica's proprietary PPG and EDA sensors, EmbracePlus is the only medically certified smartwatch that enables continuous EDA monitoring in addition to the continuous monitoring of vital parameters, an important parameter in the research areas of neurology and psychiatry. EmbracePlus also enables the development and monitoring of digital biomarkers, i.e. the output of data prepared by algorithms. An example is Aura from Empatica that can detect the early onset of respiratory infections, including flu and COVID-19.

EmbracePlus was developed to improve remote and passive data collection from participants in clinical trials, which has become increasingly important since the pandemic. Clinical trials rely on extensive patient data, but the collection of such data is traditional expensive, time-consuming and error-prone. Clinic visits only capture snapshots of a patient's state of health, e.g. an electrocardiogram or a phenotype analysis, and require the patient to take time for work and family. Wearables collect patient data from home over long periods of time, resulting in extensive data sets. The combination, quality, and scope of data remotely collected by EmbracePlus can enable the creation of novel digital endpoints so that clinical trials can be patient-centered while uncovering new insights.

Empatica CTO Simone Tognetti stated, “EmbracePlus is the result of years of hard work by our team and culminates 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 realize our vision of helping millions of patients with new insights into their health and ultimately better care. "

EmbracePlus was 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, a digital health company headquartered in Boston, Massachusetts with offices in Milan, Italy and Seoul, South Korea, is a pioneer in digital biomarker development and continuous patient monitoring through AI. Empatica's smartwatches are FDA-approved and CE-marked and have been sold to thousands of institutional partners for clinical trials and research in studies investigating depression, addiction, stress, oncology, epilepsy, migraines and other diseases.

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