Empatica Debuts Health Monitoring Device for Clinical Trials

Empatica recently unveiled EmbraceMini, a new wearable for clinical trials that offers seamless and non-invasive activity data collection while prioritizing the patient experience.

EmbraceMini is an ultra-compact health monitoring device that reportedly delivers exceptional wearability and high-quality data without compromising sponsor or participant needs, according to Empatica. It wirelessly transmits sensor data to the U.S. Food and Drug Administration (FDA)-cleared Empatica Health Monitoring Platform, enabling clinicians to continuously analyze and extract precise digital biomarkers from clinical trial participants while boosting compliance.

“We’ve created a wearable that combines the reliability of a medical device with the accessibility of a design accessory, something previously missing from the market,” Empatica Co-Founder/Chief Technology Officer Simone Tognetti said. “Most devices adopted in clinical trials today are too bulky, or just not fit for purpose. Wearability is crucial for the success of the study, so our goal with EmbraceMini was to make a compact, beautiful wearable that offers the same data quality and range as EmbracePlus, without ‘competing’ with people’s favorite watches or accessories for room on their wrist.”

At 12mm thick and 14mm wide (the size of an AA battery), EmbraceMini is the world’s smallest wrist-worn actigraphy device for clinical research, Empatica executives claim. It is purpose-made for studies that track sleep and movement, with a long battery life that can achieve at least seven days of continuous data collection.

EmbraceMini can passively monitor more than 200 digital measures, including digital biomarkers across physical activity, sleep, gait, and light exposure. These can serve a key role as digital endpoints in trials on sleep disorders, movement disorders, obesity, depression, pain, and more. In addition, EmbraceMini can collect raw sensor data, providing more transparency and flexibility in how information can be processed.

Thanks to Empatica’s modular approach, EmbraceMini can be worn on the wrist, leg, around the waist, or the ankle. Empatica allows simultaneous data collection using multiple devices, so researchers can combine data from Empatica’s flagship wearable EmbracePlus (including cardiorespiratory measures) and EmbraceMini, or use two EmbraceMini units worn at different body locations for richer insights.

Besides working seamlessly with Empatica’s software, EmbraceMini can also be integrated into existing clinical trial management systems using a Cloud API.

FDA clearance for EmbraceMini is expected later this year.

Empatica develops continuous, unobtrusive remote health monitoring solutions driven by artificial intelligence. Empatica’s FDA-cleared platform and technology are used by thousands of institutional partners for research purposes, in studies examining stress, sleep, epilepsy, migraine, depression, addiction, and other conditions. Its flagship medical wearable, EmbracePlus, has been developed with key partners including HHS, USAMRDC, and the NASA-funded TRISH.