Empatica
fda-cleared

Empatica Health
Monitoring Platform
for Clinical Trials

Designed for the patient, enhanced for the scientist

Reduce patient and site burden while enhancing data quality. Use industry-leading wearable technology and validated digital biomarkers to collect data remotely, continuously, and unobtrusively, with instant access via the cloud.

Talk to our team

The world’s most versatile sensor platform for physiological data collection and digital endpoint development

Combining award-winning design, state-of-the-art sensors, and unprecedented flexibility, Empatica’s clinical trials solution is a modular platform that enables data to be accessed and downloaded both in an uncomputed raw format and in the shape of digital biomarkers, freeing up research and health monitoring needs to go as deep or as broad as needed.

A seamless trial experience

Conducting trials at scale from patients’ homes has never been easier.

For patients

  • EmbracePlus is a medical device that integrates with everyday life. It is designed to be worn all day long, while streaming physiological parameters to a companion app via Bluetooth®.
  • Data collection is passive, automatic, and continuous, requiring no input from patients.
  • Onboarding is fast, easy and can be done remotely, while added features enhance patient engagement and aid troubleshooting where needed.
Discover what makes EmbracePlus unique

For sites

  • Enrollment and data collection are done remotely through the Empatica Care platform, with the support of a dedicated team and material to cover site and patient needs.
  • Collected data are streamed automatically from the Care app to the cloud, from where they can be accessed instantly, requiring no manual input or site visits from patients, and enabling the simultaneous monitoring of thousands.
  • Sites receive frequent adherence reports via email, so that staff can quickly intervene when they identify compliance issues.
Explore Empatica Care

For clinical researchers

  • EmbracePlus is built in partnership with NASA, HHS, and USAMRDC, and packs the highest number of sensors found in a wrist-worn device.
  • Fast and secure access to your data through the cloud is available 24/7, in the form of digital biomarkers, reports, and sensor raw data.
  • All data points are timestamped, enabling researchers to dive deep into the details of each occurrence.
Find out more about our digital biomarkers

SLEEP APNEA STUDY

Sleep Revolution H2020

The Sleep Revolution, an interdisciplinary international research and development project, aims to develop a smart, personalized diagnostic and therapeutic solution for sleep-disordered breathing (sleep apnea). Using the EmbracePlus smartwatch, the study entails developing Machine Learning models to determine the severity and treatment needs of people with sleep apnea, for accurate diagnosis and improved treatment.

ADHD STUDY

Timespan H2020

TIMESPAN, a consortium of 17 institutions from 14 countries has launched the ART-CARMA project, to study the management of chronic cardiometabolic disease and treatment discontinuity in adult ADHD patients. Using EmbracePlus, the project aims to understand the risks of cardiometabolic illnesses such as cardiovascular disease and obesity for adults with ADHD, and how their future health can best be improved through medication.

DIGITAL ENDPOINT VALIDATION STUDY

VeraSci

VeraSci’s Innovation Lab has been conducting an NIH-funded study examining the relationship between real-time measurements of gait and actigraphy, collected by the Embrace2, and established cognitive and functional endpoints that are sensitive to decline early in the Alzheimer’s disease continuum. Their preliminary data suggest a positive correlation between in-clinic measurements and the endpoints developed using Embrace2 data for monitoring the patient's cognitive health.

Download the case study

DRUG EFFICIENCY TRIAL

Sunovion Pharmaceuticals

Sunovion Pharmaceuticals utilized Empatica Health Monitoring Platform during their international multi-site phase-4 anti-epileptic drug trial. Empatica’s FDA-cleared seizure detection algorithm and the e-diary app allowed Sunovion to continuously monitor patients, gaining an objective insight into seizure counts while remotely monitoring compliance throughout the study.

FLU PREVENTION STUDY

Biomedical Advanced Research and Development Authority

The US government’s Biomedical Advanced Research and Development Authority (BARDA) has partnered with Empatica to develop a digital endpoint for detecting the earliest signs of the flu. Through the use of the Embrace2 wearable and Empatica data analysis expertise, they engaged in a prospective study monitoring healthy individuals throughout the flu season with the aim to develop an early detection system. Following the outbreak of the Covid-19 pandemic, BARDA and Empatica renewed their partnership to utilize EmbracePlus and the Care suite for Covid-19 early detection.

MENTAL HEALTH STUDY

Harvard University

Harvard University Clinical Psychologist Dr. Matthew K. Nock is using Embrace for Research to detect digital phenotypes related to suicidal thoughts in a multi-site study involving hundreds of individuals wearing Embrace2. This is the largest-yet study about suicidal behavior also measuring skin conductance levels as an objective way to assess changes in physiological distress in the participants.

BIOFEEDBACK

4YouandMe

4YouandMe, a non-profit company founded by Dr. Stephen H. Friend has partnered with clinicians at Oxford University and Mount Sinai School of Medicine to conduct a multi-site prospective cohort study, utilizing Empatica wearables to monitor signs of stress and symptoms of Crohn's disease. The aim of this project is to provide biofeedback to patients with Crohn’s, in order to potentially prevent negative clinical changes in their condition.

ZERO GRAVITY STUDY

MIT Media Lab

MIT Media Lab’s doctoral student, Kristina T. Johnson has embarked on a journey to measure autonomic changes in parabolic flyers. Parabolic flight planes are notorious for inducing high levels of nausea. By using Empatica’s technology and other biosignal measures, Kristy and her team were able to gain an objective insight into novice and veteran flyers’ physiological well-being during flights.

DIGITAL THERAPEUTICS

Pear Therapeutics

Pear Therapeutics, the leader in prescription digital therapeutics, is using Empatica’s technology to explore using wearable sensors in the evaluation of withdrawal symptoms in patients with substance use disorder (SUD), opioid use disorder (OUD), and alcohol use disorder (AUD). Using the EmbracePlus smartwatch, Pear Therapeutic aims to integrate real-time personalization of digital therapeutic content and pharmaceutical dosing to patients across disease stages.

Why Empatica

By researchers, for researchers

Our data science legacy and MIT origins ensure our solution is built with data scientists’ needs in mind. Data come in an accessible, uncomputed raw format, or as validated digital biomarkers, and are instantly ready for analysis.

A track record in building medical devices

EmbracePlus is built in partnership with NASA, the USAMRDC and HHS. Our FDA-cleared Embrace2 is used by thousands of people who live with epilepsy, while our E4 wristband has helped publish over 1,000 academic papers.

Design that integrates with everyday life

EmbracePlus has been designed to be a pleasure for patients to wear, making it the missing link between medical devices and consumer wearables.

A committed team that knows your needs

We provide accelerated timelines, with immediate deployment and dedicated onboarding that can be delivered within weeks.

Support at every step of the way

All our clients benefit from dedicated onboarding, an account manager, and site support to walk you through every step of the process

We handle the logistics and provide IRB materials so you can focus on your research

Dedicated customer and technical support across continents, providing prompt assistance when needed

Start collecting data in less than 5 minutes with auto-generated, secure QR codes for patient enrollment

The only tool you need to develop novel digital endpoints for your clinical trials

The Empatica platform is entirely created in-house, from the hardware and software, to the SDK and cloud infrastructure that gather and store the data, making it a fully integrated and flexible solution that adapts to your research needs.

A full-stack, unified solution that’s built to work together

EMBRACE PLUS

EmbracePlus continuously measures and records physiological parameters, which are sent via Bluetooth® to the Care app

CARE APP

The Care app uses the phone’s internet connection to automatically transfer all data to the Empatica cloud

EMPATICA CLOUD

The cloud securely stores data and makes it available for immediate access, either via direct download or through online visualization on the Care Portal

CARE PORTAL

The Care Portal allows you to manage your studies and visualize data and biomarkers over time, and across sites

Use in your own cloud: combine Empatica’s hardware and software for data collection and streaming

EMBRACE PLUS

EmbracePlus continuously measures and records physiological parameters, which are sent via Bluetooth® to the Care app

CARE APP

The Care app uses the phone’s internet connection to automatically transfer all data to the Empatica cloud

EMPATICA CLOUD

The cloud securely stores data and makes it available for immediate access

YOUR CLOUD

Access your data directly from your cloud, both in raw format and as digital biomarkers

Use EmbracePlus in your own application, with the flexibility to build your own software and biomarkers

EMBRACE PLUS

EmbracePlus continuously measures and records physiological parameters, which are sent via Bluetooth® to a companion app

CUSTOM APP

Build your own custom app using the Empatica SDK, to process, visualize and stream EmbracePlus data as you wish

YOUR INFRASTRUCTURE

Implement in your own infrastructure, or access your data directly from your cloud, both in raw format and as digital biomarkers

Sensor modes

Sensor modes are predefined configurations for EmbracePlus that enable the device to focus on collecting specific parameters that are key to your study. Talk to our team to find out how sensor modes can enhance the data collection capabilities of the Empatica Health Monitoring Platform.

Actigraphy Pro

  • 7-day battery life
  • All actigraphy digital biomarkers and raw accelerometry data included
  • 64Hz sampling rate
  • Plus Wearing Time, EDA, and Temperature

Actigraphy Optimized

  • 14-day battery life
  • All actigraphy digital biomarkers and raw accelerometry data included
  • 32Hz sampling rate

SpO2 Pro

  • 64 Hz PPG sampling rate
  • High-quality SpO2 and Pulse Rate measurements plus additional sensor data and digital biomarkers
  • Full suite of reports

Pulse rate Pro

  • 64 Hz PPG sampling rate
  • High-quality Pulse Rate measurements plus additional sensor data and digital biomarkers
  • Full suite of reports

Potential savings per patient

Using Electronic Data Capture (EDC) can result in significant savings throughout all the phases of clinical trials. This graph illustrates an estimation of how much a pharmaceutical company can save per patient in each phase if using a solution like Empatica’s.

Phase I
Phase II
Phase III
Phase I

Total saving per patient 
(Phase I)

$367

Total saving per patient 
(Phase I and II)

$6,274

Total saving per patient 
(Phase I, II and III)

$12,869

Thousands of papers have been published using our solutions

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.

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.

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.

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.

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 publications

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.

Wondering if our solution fits your needs?

Reach out and a member of our team will be in touch with you as soon as possible.

Talk to our team

Your Cart

Your cart is currently empty.

Go to Store
ItemPrice (USD)
X

Select your Location

Embrace is currently available only in English. Embrace is an investigational device in the USA and a medical device in the EU. If you do not see your country listed, please visit the International site.
Please note that Embrace Alert System is not available in the following countries .