Empatica unveils ultra-compact wearable for clinical trials

Empatica launches ultra-compact wearable for clinical trials: ©Empatica

Empatica, a manufacturer of wearable health monitoring and AI-driven digital biomarkers, has introduced EmbraceMini, a new ultra-compact wearable designed specifically for clinical trials.

Billed as the smallest wrist-worn actigraphy device available for research, EmbraceMini is engineered to maximize both wearability and data quality. At just 12mm thick and 14mm wide—roughly the size of an AA battery—the device supports continuous data collection for at least seven days and passively tracks over 200 digital health measures, including physical activity, sleep, gait, and light exposure.

“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, CTO and co-founder of Empatica. “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.”

EmbraceMini transmits data wirelessly to the FDA-cleared Empatica Health Monitoring Platform, enabling the extraction of precise digital biomarkers that support study endpoints in areas such as sleep disorders, depression, pain, and obesity. It can be worn on the wrist, ankle, waist, or leg and can operate alongside other Empatica devices for multi-site data collection.

The device is currently awaiting FDA clearance, which the company expects by late 2025.

Wearables in clinical trials: Smaller devices, bigger data

The release of EmbraceMini reflects a growing trend in clinical research: the integration of highly wearable, sensor-packed devices that collect real-world, real-time health data. As decentralized and hybrid clinical trials become more common, digital tools like Empatica’s new wearable are helping improve patient compliance while enhancing the granularity and reliability of data.

Recent advances in the sector have focused on increasing the number of measurable endpoints while reducing the size and burden of the device itself. Many next-generation wearables now passively monitor a wide range of digital biomarkers, from heart rate variability and gait patterns to sleep quality and behavioral changes—all key indicators in trials for chronic diseases, neurodegenerative conditions, and mental health disorders.

Battery life and data interoperability have also improved. Devices like EmbraceMini are capable of running for a full week on a single charge, and their cloud-based platforms can often be integrated into existing clinical trial management systems, streamlining workflows for research teams.

Furthermore, machine learning algorithms increasingly help identify trends in patient data faster than traditional methods, potentially accelerating both the discovery and approval phases of new therapies.

With regulators like the FDA and EMA showing greater openness to the use of digital endpoints, wearables are likely to play a pivotal role in the future of evidence generation—making trials not only faster and more cost-effective, but also more reflective of real-world patient experiences.