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Empatica Health Monitoring Platform for Clinical Trials

Empowering clinical research with high-precision digital measures

Enhance your decentralized clinical trials with validated digital biomarkers and raw physiological data of the highest quality, from an FDA-cleared, full-stack platform designed to reduce patient and site burden across every therapeutic area. Conducting research at scale from patients' homes has never been easier.

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Scale your research across studies and therapeutic areas with a single platform

Scalable

Scalable across studies and geographies, with simultaneous data collection from thousands of devices and multiple language support

Modular

One multi-use, adaptable wearable that can be worn across different areas of the body depending on your study needs

Reliable

Secure and compliant FDA-cleared technology and dozens of accurate digital measures, for guaranteed quality data

<2 months

from contract signing to starting data collection in your decentralized trial

>90% compliance

with EmbracePlus used as an actigraphy sensor¹

120+ Industry sponsored trials

have already implemented our Platform across multiple therapeutic areas

1. Feasibility of implementing wearable technologies for in-home assessment of behavioral and event-related potential responses after sleep and wakefulness in Alzheimer disease

The only tool you need to remotely collect health data for your decentralized trials

Empatica's end-to-end platform covers every step of a decentralized clinical trial: remote patient enrollment, wearable device provisioning and shipping, continuous automated data collection, and clinical data management. Whether you are running a Phase IIa study or a global Phase III pivotal trial, the same platform, the same devices, and the same data quality apply.

Designed for the patient

  • Reduce burden and maximize compliance in decentralized research
  • All data is collected via Empatica’s medical-grade wearables, with a modular design, comfortable materials, waterproof capabilities, and extended battery life, designed to be worn in daily life
  • Data is streamed via a smartphone app that is simple to use and install on popular smartphone models. The app is translated into over 40 languages, with more continuously being added, allowing you to enhance diversity in your research without disadvantaging participants
  • Setup is fast and easy, and can be done autonomously with the support of dedicated patient materials
  • Battery life can last up to 28 days, reducing charging time

Made to support global trial operations

  • Remote and secure enrollment, participant, and study management through the Care Portal
  • Data collection and streaming to the Cloud is continuous and automated, thanks to the EmbracePlus and EmbraceMini capabilities
  • Continuous support by a dedicated team, help desk, and materials, covering site and patient needs across every step of your study
  • Empatica’s experienced team handles all logistics, including device shipping, replacement, and returns
  • Sites receive frequent adherence reports via email, so that staff can quickly intervene when they identify compliance issues
  • Regulatory support and audit trails, including IRB/Ethics committee-friendly materials
  • Empatica performs frequent testing and certification of new phone models, and provides provisioned phones, to ensure technological compatibility

Validated across therapeutic areas

  • Neurology & movement disorders support digital biomarker assessment through multimodal biosignals (EDA, PPG, actigraphy)
  • CNS, psychiatry & mental health support insights into sleep, circadian rhythms, stress, and activity patterns
  • Oncology & rare disease support fatigue, mobility, and functional activity outcomes
  • Cardiovascular supports heart rate, HRV, IBI, and pulse dynamics
  • Pain & musculoskeletal supports gait, activity, and sleep disruption
  • Sleep disorders support TST, WASO, SOL, sleep efficiency, and rest–activity rhythms
  • Metabolic & obesity support activity, sedentary time, sleep quality, and circadian disruption

Enhanced for the scientist

  • Purpose-made for remote data collection, the Empatica Health Monitoring Platform is FDA-cleared and developed to provide researchers with medical-grade data, collected continuously from participants’ homes
  • Accelerate treatment research with over 300 clinically validated and research-grade digital biomarkers that can be used as digital endpoints in your trials
  • Develop your own digital biomarkers using high-frequency raw data from the EmbracePlus sensors
  • Visualize digital biomarkers and patient data inside the Care Portal, spotting patterns and adverse events
  • Support eCOA and ePRO data collection strategies, providing continuous, sensor-derived measures for use in regulatory submissions

Powered by EmbracePlus

  • The world’s most advanced and versatile medical device
  • 5x powerful sensors: PPG, EDA, Skin Thermometer, Accelerometer and Gyroscope
  • Fully adaptable to the needs of your study; balance power with battery consumption and data quality using preconfigured sensor modes, including Actigraphy modes
  • Taking health monitoring beyond the wrist, EmbracePlus can be combined with different accessories such as a belt clip and an elastic strap to be worn across different areas of the body
Learn about EmbracePlus

EmbraceMini: The perfect actigraphy wearable

  • Compact and discreet, ideal to be worn next to a favourite watch or accessory
  • 4x sensors: Accelerometer, Gyroscope, Magnetometer, Ambient Light Sensor
  • 14+ days of battery
  • The smallest actigraphy wearable validated for clinical research
  • Fully modular
Learn about EmbraceMini

Seamless study management through the Care Portal

Centralize wearable data, digital biomarkers, and compliance metrics in a secure, web-based platform, giving sponsors, CROs, and site teams audit-ready visibility across every participant, site, and geography throughout the study.

  • Manage multiple studies and sites through a secure online portal
  • Easily enroll and manage participants
  • Visualize patient data and digital biomarkers across timeframes
  • Wearing time reports and dashboards

Explore Care

The largest and most trusted selection of digital biomarkers in research

  • Over 300 digital biomarkers, including dozens of sleep and activity measures
  • 6 FDA-cleared measures
  • Data visualization directly inside the Care Portal
  • Algorithm integrations from trusted partners

Discover our range of digital biomarkers

Achieve multifaceted trial outcomes with double-device monitoring

Monitor each participant using 2x devices, in any form factor of your choice. Data flows into a single app installed on participants’ phones, ensuring the same, low-burden experience.

Build complementary datasets

Track vitals and other specialized digital biomarkers alongside actigraphy data, with 300+ digital measures to choose from.

Discover correlations

Reveal important correlations that single-device monitoring can miss with accurate and in-sync time-stamping.

Achieve more accuracy and versatility

Combine data collected from different body parts, such as lumbar and waist monitoring with wrist data.

Design more sophisticated protocols

Leverage the ability to capture different types of digital endpoints simultaneously, and demonstrate the reliability of your study.

Streamline clinical trials with Empatica’s Cloud API

Seamlessly integrate the Empatica Health Monitoring Platform into your existing clinical trial management system (CTMS) with our Cloud APIs.

  • Reduce study complexities with seamless data flow
  • Leverage Empatica’s 300+ digital measures and FDA-cleared medical wearable
  • Manage EmbracePlus users directly from your own software

Learn more

Empatica Actigraphy

Explore a comprehensive range of sleep and activity endpoints used in clinical research, including TST, WASO, sleep efficiency, rest-activity rhythm, and circadian disruption indices, supporting sleep studies, fatigue endpoints, and actigraphy-based clinical outcome assessments in decentralized trials.


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Regulatory and Compliance

Empatica’s constant and decisive efforts aim at ensuring the safety, effectiveness, and quality of its medical devices as well as providing products that meet customer and applicable statutory and regulatory requirements


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Thousands of papers have been published using our technology

We collaborate with the best research teams in the world to advance the understanding of human health in real-life settings. Our work is focused on measuring and quantifying the impact of wearable technology in health, while our products have been used in a breadth of contexts, from large-scale clinical trials to intimate academic studies.

Detecting Moments of Stress from Measurements of Wearable Physiological Sensors

This research aims to bridge the gap between laboratory settings and real-world field studies by introducing a new algorithm that leverages the capabilities of wearable physiological sensors to detect moments of stress (MOS).


Results: our results overall demonstrate that stress can be reliably detected with an accuracy that varies from 75 to 100%, with an average of 84%. [...] the defined critical values are tailored to the current research, they do not serve as global values for stress detection.

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Using wearable technology to detect prescription opioid self-administration

The current work examined the use of a wearable sensor to detect self-administration of opioids after dental surgery using machine learning.


Results: results from training and testing model of machine learning indicated that opioid self-administration could be identified with reasonable accuracy, leading to considerable possibilities of the use of wearable technology to advance prevention and treatment.

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Engineering digital biomarkers of interstitial glucose from noninvasive smartwatches

This study outlines a novel machine learning model which predicts interstitial glucose levels using non-invasive measurements with impressive accuracy.


Results: the study demonstrated the feasibility of using noninvasive and widely accessible methods, including smartwatches and food logs recorded over 10 days, to continuously detect personalized glucose deviations and to predict the exact interstitial glucose value in real time with up to 84% and 87% accuracy, respectively.

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Integrating a Mobile Health Device Into a Community Youth Mental Health Team to Manage Severe Mental Illness: Protocol for a Randomized Controlled Trial

The aim of this study is to examine (1) whether an mHealth device integrated into a community mental health team can improve outcomes for young adults with severe mental illness and (2) whether the device detects periods of mental health versus deterioration.


Results: coming at the end of the study.

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Ictal autonomic activity recorded via wearable-sensors plus machine learning can discriminate epileptic and psychogenic nonepileptic seizures

The study demonstrates that epilpetic and psychogrenic non-epileptic seizures can be discriminated based on signals related to autonomic nervous system activity recorded via wearable sensors.


Results: classification performance achieved a predictive accuracy of 78 ± 1.5% on previously unseen data for whether a seizure was epileptic or psychogenic.

Read more
View our publications

Frequently Asked Questions

How does Empatica ensure regulatory compliance in clinical trials?

Empatica's platform is built to meet the regulatory standards required for use in sponsored clinical trials. EmbracePlus and EmbraceMini are FDA-cleared medical devices and CE MDR certified under EU Medical Device Regulation 2017/745. All data is stored and transmitted in compliance with 21 CFR Part 11, HIPAA, and GDPR. The platform generates complete audit trails, supports IRB and ethics committee submissions with purpose-built documentation packages, and undergoes regular independent quality audits. Empatica's regulatory team provides direct support throughout the submission process, including device validation documentation, protocol-specific IFU materials, and post-market surveillance reporting.

What therapeutic areas has Empatica's platform been used in?

Empatica's platform has been deployed across 120+ industry-sponsored trials in neurology (including epilepsy and seizure monitoring), CNS and psychiatry, oncology, rare disease, cardiovascular, sleep medicine, and pain and musculoskeletal conditions. In neurology, EmbracePlus carries FDA clearance for tonic-clonic seizure detection, one of only a handful of wearable devices with this clearance. In CNS and sleep research, EmbraceMini's actigraphy suite delivers the full set of sleep endpoints (TST, WASO, sleep efficiency) required by FDA and EMA guidance documents. Empatica's clinical team can advise on device selection, sensor configuration, and endpoint selection for your specific indication.

How long does it take to get started with Empatica for a new trial?

Empatica's average time from contract signing to first patient data collection is under two months, significantly faster than custom-built or multi-vendor solutions. The onboarding process includes protocol design support, device configuration to your sensor mode requirements, Care App localisation for your study languages, site training materials, and logistics setup for device shipping and returns. Empatica handles all hardware provisioning, including phone compatibility testing and provisioned phones if required by your protocol. For multi-site or global trials, the same onboarding workflow scales without requiring additional vendor integrations.

What makes Empatica's digital biomarkers suitable for regulatory submissions?

Empatica's digital biomarkers are derived from FDA-cleared hardware and validated against clinical gold standards across peer-reviewed publications. Six measures carry direct FDA clearance. The broader library of 300+ measures is research-grade and designed to meet the FDA's Digital Health Technology guidance framework and the V3 (Verification, Analytical Validation, Clinical Validation) framework for digital endpoint qualification. Empatica provides algorithm documentation, validation study references, and regulatory submission support materials, including device descriptions suitable for IND, NDA, and BLA filings, through its dedicated regulatory affairs team.

How does Empatica support patient compliance and data completeness?

Empatica's >90% compliance rate across actigraphy studies reflects deliberate device and UX design choices. EmbracePlus and EmbraceMini are lightweight, waterproof, and designed to be worn alongside everyday accessories. The Care App supports 40+ languages and is installable on all major Android and iOS smartphones, with an onboarding flow participants can complete independently. Battery life of up to 28 days (EmbracePlus) and 14+ days (EmbraceMini) minimises charging interruptions. Site staff receive automated adherence reports by email, enabling early intervention when compliance dips, and Empatica's help desk provides direct participant support across all geographies.

Can Empatica's devices be used across different body locations?

Yes. EmbracePlus supports multi-body monitoring through a modular accessory system, including a wrist strap, belt clip, and elastic strap, allowing lumbar, waist, and wrist placement in the same study. Two devices can be deployed per participant simultaneously, with all data flowing into a single Care App instance. This enables combined endpoint strategies, for example, pairing wrist-based PPG and EDA data with lumbar accelerometry for gait analysis, without increasing app complexity for the patient. EmbraceMini is optimised for wrist actigraphy and designed to be worn discreetly alongside a personal watch.

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