Empatica Launches World's Smallest Clinical Trial Wearable Device for Digital Biomarker Collection
Key Insights
Empatica (search) unveiled EmbraceMini (search), the world's smallest wristworn actigraphy device for clinical research, measuring just 12mm thick and 14mm wide.
The ultra-compact wearable can passively monitor over 200 digital measures including sleep, movement, and gait patterns for clinical trials studying various conditions.
EmbraceMini (search) wirelessly transmits data to Empatica (search)'s FDA-cleared platform and is expected to receive FDA clearance in late 2025.
Empatica (search), a pioneer in digital biomarker development and patient monitoring using wearables and AI, has unveiled EmbraceMini (search), positioning it as the world's smallest wristworn actigraphy device designed specifically for clinical research applications.
Ultra-Compact Design Addresses Clinical Trial Challenges
At just 12mm thick and 14mm wide—comparable to the size of a USB flash drive or AA battery—EmbraceMini (search) represents a significant advancement in wearable technology for clinical trials. The device addresses a critical challenge in clinical research where traditional monitoring devices are often too bulky for sustained patient 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 Simone Tognetti, Empatica (search)'s CTO and Co-founder. "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 (search) was to make a compact, beautiful wearable that offers the same data quality and range as EmbracePlus (search), without 'competing' with people's favorite watches or accessories for room on their wrist."
Comprehensive Digital Biomarker Monitoring Capabilities
EmbraceMini (search) can passively monitor over 200 digital measures, including digital biomarkers across physical activity, sleep, gait, and light exposure. These measurements can serve as digital endpoints in trials studying sleep disorders, movement disorders, obesity, depression, and pain conditions. The device also collects raw sensor data, providing researchers with transparency and flexibility in data processing approaches.
The wearable is purpose-built for studies tracking sleep and movement patterns, featuring a battery life capable of at least seven days of continuous data collection. This extended monitoring capability is essential for capturing comprehensive baseline measurements and treatment responses in clinical trial settings.
Modular Design and Integration Features
Empatica (search)'s modular approach allows EmbraceMini (search) to be worn at multiple body locations including the wrist, leg, waist, or ankle. Researchers can simultaneously collect data using multiple devices, combining information from Empatica's flagship EmbracePlus (search) wearable—which includes cardiorespiratory measures—with EmbraceMini, or deploy two EmbraceMini units at different body locations for enhanced data collection.
The device wirelessly transmits sensor data to Empatica (search)'s FDA-cleared Health Monitoring Platform, enabling continuous analysis and extraction of precise digital biomarkers from clinical trial participants while supporting compliance monitoring. Beyond Empatica's proprietary software, EmbraceMini (search) integrates with existing Clinical Trial Management Systems through a Cloud API.
Regulatory Timeline and Clinical Applications
FDA clearance for EmbraceMini (search) is expected in late 2025. Empatica (search)'s existing FDA-cleared platform and technology are currently used by thousands of institutional partners for research purposes in studies examining stress, sleep, epilepsy, migraine, depression, addiction, and other conditions.
The company has developed its flagship medical wearable, EmbracePlus (search), in collaboration with key partners including the Department of Health and Human Services (HHS), U.S. Army Medical Research and Development Command (USAMRDC (search)), and the NASA-funded Translational Research Institute for Space Health (TRISH (search)).