BOSTON: Empatica, a pioneer in digital biomarker development and patient monitoring using wearables and AI, today unveiled EmbraceMini, its revolutionary new wearable for clinical trials.

EmbraceMini is an ultra-compact health monitoring device, focused on delivering exceptional wearability and high-quality data without compromising sponsor or participant needs. With its incredibly small footprint and refined looks, EmbraceMini offers effortless, seamless and non-invasive activity data collection while prioritizing the patient experience at all times. It wirelessly transmits sensor data to the FDA-cleared Empatica Health Monitoring Platform, enabling the continuous analysis and extraction of 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,” said Empatica’s CTO and Co-founder, Simone Tognetti. “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 just 12mm thick and 14mm wide, EmbraceMini is the smallest wristworn actigraphy device for clinical research in the world – the size of an AA battery. It is purpose-made for studies that track sleep and movement, with a long battery life that can achieve at least 7 days of continuous data collection.

EmbraceMini can passively monitor over 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 in late 2025. If you are interested in learning more about the device and to request a demo, visit empatica.com/embracemini or write to Empatica at research@empatica.com.

Empatica

Empatica Inc is a pioneer in continuous, unobtrusive remote health monitoring driven by AI. 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.

Fonte: Business Wire