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FDA Clears Digital Health Monitoring System

EmbracePlus device

EmbracePlus device (Empatica)

23 Nov. 2022. A developer of remote health tracking technology says the Food and Drug Administration cleared its continuous patient monitoring system for clinical use. Empatica, in Boston, says its Health Monitoring Platform that collects data from its own wearable device, is authorized by FDA to collect real-time data on four digital health indicators for home patient care.

Empatica says its health monitoring technology connects patients or clinical trial participants through a mobile app to the cloud, where their data are analyzed by algorithms and tracked by clinicians. Individuals using the company’s health monitoring technology wear a device resembling a smart watch called EmbracePlus that Empatica says contains sensors measuring a range of physiological indicators.

As reported by Science & Enterprise in Feb. 2018, Empatica first designed the Embrace smart watch to capture electro-dermal activity or EDA activity on the skin as an indicator of convulsive seizures in people with epilepsy. Signals captured by the watch are then analyzed with machine learning algorithms, based on research by Rosalind Picard, director of MIT’s Affective Computing group, and a founder of the company. A year later, Empatica added respiratory functions to the Embrace watch indicators to track flu cases, with funding from Biomedical Advanced Research and Development Authority in the U.S. Department of Health and Human Services.

Second venture funding round

The EmbracePlus device now tracks photoplethysmography or PPG, an optical technique for measuring blood volume under the skin, and includes an accelerometer and gyroscope, as well as temperature and EDA sensors. Data from EmbracePlus are sent via Bluetooth to a smartphone app that transfers the data to an Empatica cloud system for analysis by algorithms and visualization. Clinicians can then download the data for further analysis.

The company says its health monitoring technology is currently used for clinical trials and other research studies. The new FDA clearance, says Empatica, authorizes the system for patient care monitoring of four functions: EDA, blood oxygen saturation during rest, skin temperature, and sleep movements. The company says its system enables real-time home tracking of patients with acute or chronic conditions, as well as healthy individuals at risk of infection.

“This clearance represents a significant step forward for our scientific community,” says Empatica chief medical officer Marisa Cruz in a company statement released through Cision. “Patients, health care providers, and researchers deserve digital health products that are accurate, validated in diverse populations, and intuitive to use.”

Empatica also says the company is raising new funds in its series B or second venture funding round. The financing is led by Sanofi Ventures, the drug maker’s investment division, and life science/health care investor RA Capital Management in Boston, with participation by Black Opal Ventures. While the company is not disclosing the amount raised in the round, Crunchbase reports in August Empatica raised some $26 million in its series B funding round, from Black Opal Ventures and two other investors.

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