" class="no-js "lang="en-US"> Empatica’s EmbracePlus Wins CE Mark for Quality Physiological Data Collection - Medtech Alert
Saturday, February 24, 2024

Empatica’s EmbracePlus Wins CE Mark for Quality Physiological Data Collection

EmbracePlus by Empatica has received the European CE mark as a Class lla medical device, for its ability to consistently provide quality physiological parameters to users. EmbracePlus is a medical smartwatch that continuously and remotely collects and processes physiological signals from the wrist, including pulse rate, pulse rate variability, blood oxygenation, respiratory rate, skin temperature, electrodermal activity, rest, and actigraphy data.

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. Data can be streamed simultaneously from thousands of devices. This is possible both via Empatica software and third party-applications that can be 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 fields of neurology and psychiatry research. EmbracePlus also enables the development and monitoring of digital biomarkers, the output of data reprocessed by algorithms. An example is Empatica’s Aura, which can detect the early onset of respiratory infections, including influenza and COVID-19.

EmbracePlus is built to enhance remote and passive data collection from clinical trial participants, which has become increasingly prevalent since the pandemic. Clinical trials depend on rich patient data, yet collecting such data has traditionally been expensive, time-consuming, and error-prone. Clinic visits only capture snapshots of a patient’s health, i.e., one electrocardiogram or phenotype analysis, and require patients to take time away from their work and family. Wearables track patient data from patients’ homes over large time periods, resulting in rich datasets. 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.

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.”

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.

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