US-based digital healthcare company Empatica has secured CE mark approval for its EmbracePlus medical smartwatch.
EmbracePlus, which has been approved as a Class lla medical device, will help continuously and remotely collect and process physiological signals from the wrist.
The physiological signals consist of pulse rate, pulse rate variability, blood oxygenation, respiratory rate, skin temperature, electrodermal activity, rest and actigraphy data.
EmbracePlus allows to continuously send the data to a smartphone app. Through a single portal, it will be transferred to the cloud for review and analysis by clinical researchers and healthcare professionals.
According to the company, Empatica software and third-party applications developed using Empatica’s SDK will help stream data from thousands of devices.
Featuring the firm’s advanced PPG and EDA sensors, EmbracePlus facilitates continuous vital signs monitoring alongside continuous EDA monitoring.
The smartwatch also allows to develop and monitor digital biomarkers, the output of data reprocessed by algorithms.
Empatica’s Aura, which is one of the digital biomarkers, helps to identify the early onset of respiratory infections such as influenza and COvid-19.
Empatica CTO Simone Tognetti said: “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 has worked with partners such as HHS, USAMRDC, and the NASA-funded Translational Research Institute for Space Health for the development of a new medical smartwatch.
The company’s smartwatches are used by institutional partners for clinical trials and research in studies evaluating depression, addiction, stress, oncology, epilepsy, migraine and other conditions.
In June last year, Empatica collaborated with the Biomedical Advanced Research and Development Authority (BARDA), to validate a wearable system that offers early warning for Covid-19 and other respiratory infections.
