Empatica Care

by Empatica S.R.L.  · Based in Italy → — AI-powered remote health monitoring for clinical research and patient care.
Cardiology Internal Medicine Neurology
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Regulatory Status Disclosed

Overview

Empatica Care is a core component of the Empatica Health Monitoring Platform, a comprehensive solution for remote health monitoring and data collection. It is *not* a physician directory tool. The platform leverages medical-grade wearable devices, such as EmbracePlus, to continuously collect physiological data from patients and trial participants. This data, including vital signs and digital biomarkers, is then securely transmitted to the Empatica Cloud via the Empatica Care App (available on iOS and Android). Healthcare professionals and researchers can access and review this data through the Empatica Care Portal, a web-based dashboard, to manage participants, monitor health trends, and facilitate clinical research. The platform is designed for professional use in clinical trials, academic research, and remote patient monitoring across various health conditions.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Continuous physiological data streaming
  • Medical-grade wearable device integration (EmbracePlus)
  • Mobile Care App for data transmission (iOS & Android)
  • Web-based Care Portal for professional review and management
  • Secure, de-identified login credentials
  • Participant onboarding and management tools
  • Visualization of patient data and digital biomarkers
  • Wearing time indicators and adherence monitoring
  • Smart troubleshooting and notifications
  • Cloud API for integration with external systems (CTMS/EDC)

Use Cases

  • Clinical trials and decentralized studies
  • Academic research
  • Remote patient monitoring
  • Epilepsy monitoring and seizure detection
  • Parkinson's disease monitoring
  • Early detection of respiratory infections (e.g., COVID-19)

What Physicians Need to Know

Evidence Base
Empatica Care is part of the Empatica Health Monitoring Platform, which is built on a foundation of scientific research. Empatica's technology has been used in thousands of peer-reviewed studies across various fields including neurology, oncology, immunology, mental health, physical health, and sleep. The platform provides access to over 300 digital biomarkers, including those developed by Empatica and integrated from partners like McRoberts, Mobilise-D, and PKG Health. The platform is designed to collect medical-grade data for clinical trials and academic research.
Clinical Validation Studies
Empatica's technology, including the EmbracePlus wearable used with Empatica Care, has undergone clinical validation. For instance, a prospective clinical validation study assessed the accuracy of the EmbracePlus wristband's reflective pulse oximeter function during controlled hypoxia, meeting FDA recommendations with an accuracy root mean square (Arms) error of 2.4%. The validation included participants with diverse skin pigmentations and sexes, showing acceptable accuracy across these groups. Empatica also highlights its pioneering work in digital biomarker development, including the first FDA-cleared digital biomarker in neurology. The platform is used by pharmaceutical companies to monitor treatment impact and develop novel digital biomarkers.
Alert Fatigue Management
While Empatica Care itself is a monitoring platform, Empatica's related Alert App (used with Embrace devices for epilepsy monitoring) includes features to manage alerts. Users can cancel false alarms directly from the device or the app, and if an alert is not canceled within 15 seconds, there's an option to notify caregivers that assistance is not needed. This indicates an awareness of the need to manage unnecessary notifications for caregivers.
Clinical Workflow Integration
The Empatica Health Monitoring Platform, which includes Empatica Care, is designed for seamless integration into existing clinical trial management systems (CTMS) and Contract Research Organization (CRO) workflows. It offers Cloud API for direct integration, allowing sponsors and CROs to manage participants and access data directly through their own systems. This includes automated participant onboarding, status management, and direct data integration. The platform aims to reduce site workload and operational overhead by automating data flow and simplifying onboarding.
Decision Audit Trail
The Empatica Health Monitoring Platform generates complete audit trails to ensure regulatory compliance, supporting submissions to IRBs and ethics committees. All data is stored and transmitted in compliance with regulations such as 21 CFR Part 11, HIPAA, and GDPR. The platform also undergoes regular independent quality audits.
Physician Tip

Empatica Care, as part of the Empatica Health Monitoring Platform, offers continuous, remote physiological monitoring using medical-grade wearables like EmbracePlus. Physicians can leverage this platform for clinical trials and potentially for clinical care in areas like Parkinson's and epilepsy monitoring. The platform provides access to a wide range of validated digital biomarkers and raw sensor data, which can offer objective insights into patient health and treatment response. The integration capabilities with existing clinical systems can streamline data flow and participant management in research settings. Physicians should note that while the Care App is part of the FDA-cleared platform, the Care Lab App and Portal are intended for research use only and not for diagnostic or clinical procedures.

The Empatica Health Monitoring Platform offers robust integration capabilities, particularly for clinical trials and research. Its Cloud API allows for direct, real-time integration with Clinical Trial Management Systems (CTMS) and Electronic Data Capture (EDC) platforms. This enables seamless participant onboarding, management of participant status, and direct access to digital biomarkers and raw data within existing cloud infrastructures. The platform also supports integration of third-party algorithms for a comprehensive set of digital biomarkers. This cloud-to-cloud integration aims to reduce operational complexities and enhance data exchange for sponsors and CROs.

Details

Category Clinical Decision Support & Reference, Wearables & Remote Monitoring (RPM)
Pricing Contact for pricing
DeploymentCloud-based
Compliance
BAA AvailableUnknown
HIPAA Compliant Yes AI-estimated
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Cardiology, Internal Medicine, Neurology

What the Web Says

Empatica Care is a remote patient monitoring platform that uses medical-grade wearables to collect continuous physiological data for healthcare professionals and researchers. It aims to provide objective health insights for personalized care, clinical trials, and managing chronic conditions like epilepsy and Parkinson's. While physicians value its reliable data and comprehensive monitoring capabilities, some users have raised concerns about subscription costs and app performance.

Overall: Mixed

Strengths

  • Provides objective, continuous, and real-world physiological data.
  • Enables more personalized care plans and a deeper understanding of disease progression.
  • Utilizes FDA-cleared and CE-certified technology for reliable data.
  • Offers a wide range of validated digital biomarkers.
  • Supports remote monitoring for various conditions, including epilepsy and Parkinson's.
  • Facilitates data collection for clinical trials and academic research.

Limitations

  • Subscription model and perceived high monthly fees have been criticized.
  • Some users report issues with the companion app, including battery drain and connectivity problems.
  • Concerns about false alerts and missed seizure detections have been raised by some users.
  • Customer support has been described as slow or poor by some users.
  • The device's battery life has been a point of criticism.
  • Limited information on interoperability with other devices.

Based on reviews from: physicianaitools.com, appbrain.com, researchgate.net, empatica.com, apkpure.com, medigy.com, dimesociety.org, reddit.com, ascelibrary.org, trustpilot.com, updatestar.com, medicaldevice-network.com, apple.com

Last updated: 2026-10-29

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Press & Coverage

empatica.com
Empatica Health Monitoring Platform receives FDA-clearance
In November 2022, the Empatica Health Monitoring Platform received FDA clearance for continuous data collection to monitor SpO2, electrodermal activity, skin temperature, and activity associated with movement during sleep. In November 2023, it received additional FDA 510(k) clearance for digital biomarkers measuring pulse and respiratory rate, expanding its capabilities for clinical research and healthcare monitoring.
2022-11
neurofounders.co
Empatica Expands Into Parkinson's Monitoring
Empatica's Parkinson's platform received FDA clearance on August 14, 2026, marking the company's 12th FDA clearance. The clearance covers the broader monitoring system, including EmbracePlus, EmbraceMini, Empatica Care, PKG Monitor, and the Care Portal.
2026-08
empatica.com
Empatica Care to simplify trial protocols
Empatica Care, combined with the EmbracePlus wearable, aims to simplify clinical trial protocols by enabling remote subject pre-enrollment, virtual setup steps, and automatic data collection, thereby reducing costs and shortening study timelines.
2022-01
empatica.com
Empatica receives first of its kind European CE mark for early detection of COVID-19
Empatica received CE mark for its respiratory infection detection system Aria and its Empatica Care remote health monitoring platform in March 2021. This certification allows the products to be marketed and used across EU Member States, with Aria being a world-first innovation for early respiratory infection detection.
2021-03
empatica.com
EmbracePlus by Empatica is now CE marked
After receiving the CE mark for Aria and Empatica Care, Empatica's EmbracePlus wearable also received the European CE mark as a Class IIa medical device in April 2021, recognized for its ability to provide quality physiological parameters.
2021-04
empatica.com
Announcing Empatica Care, a new way to remotely monitor the health of thousands
Empatica Care, a new AI-powered remote patient monitoring platform, was launched in May 2020 to enable continuous, non-intrusive vital signs monitoring for thousands of individuals from a single dashboard, utilizing Empatica's CE-certified smartband, the E4.
2020-05
mtec-sc.org
Empatica Care platform (institutional monitoring)
Empatica Care platform offers a cloud dashboard and monitoring service for real-time vital-signs monitoring across large cohorts, with role-based access and alerting for clinical and organizational use. It also includes an algorithm service for early detection and daily risk scoring of respiratory infections using wearable physiological data.
unknown
empatica.com
Monitoring skin temperature at the wrist in hospitalised patients may assist in the detection of infection
A June 2020 blog article highlighted findings from a January 2020 study in the Internal Medicine Journal, suggesting that continuous wrist skin temperature monitoring using the E4 wristband, now integrated into Empatica Care, can assist in infection detection in hospitalized patients.
2020-06

Videos

Product demos, reviews, and walkthroughs for Empatica Care.

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Frequently Asked Questions

Empatica Care is a remote patient monitoring platform that utilizes Empatica's wearable devices, such as EmbracePlus and EmbraceMini, to continuously collect physiological data and digital biomarkers from patients in their home environments. This data is then accessible to healthcare providers through a single dashboard, enabling them to monitor trends, identify cases requiring medical assistance, facilitate early intervention, and make more effective, data-driven decisions for patient care. The platform is particularly used for Parkinson's and epilepsy monitoring, providing objective insights into motor symptoms and therapy responses.
The Empatica Health Monitoring Platform, which includes Empatica Care, is FDA-cleared and CE MDR certified. Empatica also validates its regulated products to ensure compliance with regulatory requirements and industry standards like GAMP 5, and its Quality Management System is certified to ISO 13485:2016. The platform is designed to be GDPR/HIPAA compliant, ensuring data privacy and security.
Empatica Care, particularly the Embrace system, has several limitations. It does not predict seizure onset and is not intended for use during physical activity. Its safety and effectiveness for monitoring seizures other than generalized tonic-clonic convulsive seizures have not been established. The device is not intended to guide medical therapy decisions or be used as a stand-alone monitoring device. Additionally, the Empatica Health Monitoring Platform is not a substitute for an ECG monitor, is not intended for diagnostic purposes, or to be used as the sole basis for clinical decision-making.
While Empatica Care focuses on continuous physiological monitoring for conditions like Parkinson's and epilepsy, other clinical decision support tools exist depending on the specific need. For ambient AI scribes that aid in documentation and provide clinical evidence, alternatives like Empathia AI and Heidi Health are available. For seizure monitoring specifically, NightWatch+ is mentioned as an alternative that uses an upper-arm sensor and alarm station during sleep, without requiring a mobile phone or subscription.
Specific pricing for Empatica Care for clinical use is not explicitly detailed in publicly available information, but related products like EpiMonitor have a device cost and monthly subscription plans. For research purposes, bundles for the Empatica Health Monitoring Platform (including EmbracePlus or EmbraceMini devices) include data access via the Empatica Cloud and access to the Care Lab Portal for study management and data visualization for a duration of 3 or 5 years, along with ongoing service and maintenance. Academic institutions may also receive a discount.

Compare Empatica Care

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Suggest an Edit → | Report an issue | Last Verified: 2026-04-18 | First Added: 2026-04-18
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