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's Health Monitoring Platform is FDA-cleared and CE-certified, providing over 300 clinically validated and research-grade digital biomarkers. Its technology is utilized in thousands of institutional research partnerships across various conditions, including epilepsy, Parkinson's, sleep, and mental health. The platform integrates validated algorithms and digital mobility outcomes through partnerships with leaders like McRoberts and Mobilise-D. For Parkinson's monitoring, it incorporates PKG's trusted, clinically validated motor assessments.
Clinical Validation Studies
The EmbracePlus wristband has undergone prospective clinical validation for SpO2 measurements, demonstrating an accuracy root mean square (Arms) error of 2.4%, which is within the FDA's recommended 3.5% limit, across diverse skin pigmentations and sexes. Empatica is also undertaking a landmark clinical study to develop an AI-based seizure forecasting algorithm, building on prior peer-reviewed studies that successfully used their wearables for seizure prediction. An AI-based predictive algorithm for early signs of respiratory infections developed by Empatica has received CE-mark for medical use.
Alert Fatigue Management
For seizure detection, the system includes features to manage alerts, such as a 15-second window for users to cancel false alarms directly from the Alert App or the Embrace device. Users can also notify caregivers that they are fine even if the initial cancellation window is missed. Proper device wearing is emphasized to reduce false alarms.
Clinical Workflow Integration
The Empatica Health Monitoring Platform is designed for seamless integration into existing clinical trial management systems (CTMS) and Electronic Data Capture (EDC) platforms via its Cloud API. This enables streamlined participant onboarding, management, and direct access to continuous physiological data. The Care Portal allows professionals to manage participants across sites and monitor digital biomarkers, while the Care App facilitates remote data collection, live status checks, and troubleshooting for patients. The platform also integrates Electronic Clinical Outcome Assessments (eCOA), including ePROs, functional tests, and medication reminders, directly within the Care App for a unified patient experience.
Decision Audit Trail
Empatica's Health Monitoring Platform provides regulatory support and audit trails, particularly for clinical trials. This indicates that data access, modifications, and system activities are logged to ensure compliance and accountability.
Physician Tip

Empatica Care offers robust remote physiological monitoring capabilities, particularly valuable for conditions requiring continuous data collection like epilepsy and Parkinson's disease. Leverage the comprehensive digital biomarkers and raw data for in-depth patient insights and to inform treatment adjustments. Utilize the Care Portal for efficient participant management and data visualization. For seizure monitoring, educate patients on proper device wearing and the alert cancellation feature to minimize unnecessary caregiver notifications. The integrated eCOA features can provide a holistic view by combining objective physiological data with subjective patient-reported outcomes.

Empatica's Cloud API is a key integration point, allowing seamless data flow with existing Clinical Trial Management Systems (CTMS) and Electronic Data Capture (EDC) platforms. This cloud-to-cloud integration reduces operational burden and enhances data consistency. The platform also supports integration with third-party algorithms for a broader range of digital endpoints, such as those from McRoberts and Mobilise-D. The Care App is designed to work with popular smartphone models (iOS and Android) for patient data transmission.

Details

Category Clinical Decision Support & Reference, Wearables & Remote Monitoring (RPM)
Pricing Contact for pricing — Custom pricing based on deployment and specific needs; contact sales for a quote.
DeploymentCloud-based
Compliance
BAA AvailableUnknown AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status 1 AI-estimated

The Empatica Health Monitoring Platform, including EmbracePlus, Empatica Care, and Care Portal, received FDA 510(k) clearance (K242737) for physiological monitoring. It has received multiple clearances for continuous monitoring of SpO2, Electrodermal Activity, Skin Temperature, activity associated with movement during sleep, pulse rate, and respiratory rate.
Integrations
EHR Not specified
Specialties Cardiology, Internal Medicine, Neurology

What the Web Says

Empatica Care is a remote patient monitoring platform that utilizes AI-enabled wearables, like the EmbracePlus, to collect physiological data for healthcare professionals and researchers. The platform aims to provide continuous health monitoring, particularly for conditions like epilepsy and Parkinson's, and offers features like real-time vital sign tracking, automated data streaming, and detailed reports for clinicians. While it offers significant benefits for patient safety and data-driven care, some users have reported issues with the associated app's functionality, connectivity, and the company's subscription model and customer service.

Overall: Mixed

Strengths

  • Provides continuous, medical-grade physiological data monitoring.
  • Offers FDA-cleared seizure detection algorithms for adults and children.
  • Enables remote monitoring of vital signs for thousands of patients from a single dashboard.
  • Generates detailed reports on seizures, rest, and physical activity for doctors.
  • Can enhance communication between patients and clinicians with objective data.
  • Offers GPS function for locating individuals during an event.

Limitations

  • The associated app can drain phone battery quickly and have connectivity issues.
  • Users report frequent false alarms for seizure detection.
  • Subscription fees for full functionality, including caregiver notifications and seizure reports, are considered expensive.
  • Customer service has been described as unhelpful and slow to respond.
  • The app's interface and data presentation can be difficult to navigate and understand.
  • Some users report the device failing to detect actual seizures.

Based on reviews from: Empatica (empatica.com), App Store, Google Play Store, Reddit, Trustpilot, WebMD, Comparably, G2

Last updated: 2026-07-18

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Press & Coverage

Empatica Blog
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, making Aria a world-first innovation for early warning of respiratory infections.
2021-03
Empatica Blog
Announcing Empatica Care, a new way to remotely monitor the health of thousands
Empatica launched Empatica Care, a new remote patient monitoring platform that allows healthcare workers and caregivers to monitor vital signs of thousands from a single dashboard using the E4 smartband.
2020-05
HLTH
Empatica awarded new FDA clearance for cardiac digital biomarkers - HLTH
Empatica obtained FDA 510(k) clearance for two new digital biomarkers, pulse rate and respiratory rate, enhancing its Health Monitoring Platform which now includes six FDA-cleared digital biomarkers.
2023-11
Empatica Blog
The EmbracePlus wearable wins European CE mark
Empatica's EmbracePlus wearable received the European CE mark as a Class IIa medical device for consistently providing quality physiological parameters, a month after Aria and Empatica Care also received CE marks.
2021-04
BioWorld
Empatica wins CE mark for wearable-based early symptoms detection of COVID-19
Empatica Inc. secured the CE mark for its Aura system, a wearable solution for monitoring and early alert of respiratory infections, including COVID-19, for use with people aged 14 and older.
2021-03
MDPI (Sensors)
A Survey on Wearable Sensors for Mental Health Monitoring - MDPI
This peer-reviewed article mentions Empatica EmbracePlus and Empatica Care as CE certified smartwatches for continuous health monitoring, tracking patients with epilepsy, physical well-being, mental health, and respiratory infections.
2023-01
JMIR Publications (Interactive Journal of Medical Research)
A Prescription Digital Therapeutic to Support Unsupervised Buprenorphine Initiation for Patients With Opioid Use Disorder: Protocol for a Proof-of-Concept Study
This protocol for a proof-of-concept study outlines the use of the Empatica Care app and EmbracePlus for data collection and remote monitoring in patients with Opioid Use Disorder.
2023-01
Therapeutic Goods Administration (TGA)
EmbracePlus and Empatica Care - Wearable multiple vital physiological parameter monitoring system (510860) | Therapeutic Goods Administration (TGA)
This regulatory announcement from the TGA lists the Empatica Health Monitoring Platform, including EmbracePlus and Empatica Care, as a wearable multiple vital physiological parameter monitoring system.
2025-09

Videos

Product demos, reviews, and walkthroughs for Empatica Care.

View all on YouTube

Frequently Asked Questions

Empatica Care is an AI-powered remote patient monitoring platform that uses a medical-grade wearable, the EmbracePlus, to collect continuous physiological data such as heart rate, temperature, and movement. This data is streamed to a dashboard, enabling healthcare providers to monitor thousands of patients simultaneously and identify trends or potential issues for early intervention. It can be used for various conditions, including monitoring mild or severe illnesses, inpatients, outpatients, and individuals with chronic conditions like Parkinson's disease, as well as for identifying early signs of respiratory infections.
Yes, the Empatica Health Monitoring Platform, which includes Empatica Care, is designed to be both HIPAA and GDPR compliant. Patient data is securely stored and processed on HIPAA-compliant cloud infrastructure, with Empatica implementing physical, electronic, and organizational security procedures like encryption and access controls to protect data from loss or unauthorized access. Empatica emphasizes that it does not sell user data and that providers control patient information.
Empatica Care is intended for retrospective review of collected physiological parameters and is not designed for real-time data streaming or as a stand-alone diagnostic tool. It should not be used to guide medical therapy decisions or as a substitute for existing seizure monitoring practices. Additionally, the platform is not intended for use in high-acuity environments like ICUs or for acutely ill cardiac patients with life-threatening arrhythmias.
While specific pricing for Empatica Care for physicians isn't explicitly detailed in public searches, Empatica offers subscription plans for its related products, such as EmbracePlus for epilepsy monitoring, with options for monthly or annual payments. These plans vary in features, such as the number of caregivers, and volume discounts may be available for larger studies. For clinical use of the Empatica Care platform, it is generally available on an Enterprise pricing plan, suggesting a tailored approach for healthcare organizations.
While direct, like-for-like alternatives to Empatica Care as a comprehensive AI-powered remote patient monitoring platform for diverse conditions were not extensively detailed, the market for remote patient monitoring (RPM) and wellness wearables is broad. Physicians might consider other RPM solutions or EHR-integrated platforms that offer continuous physiological data collection and AI-driven insights, depending on their specific patient population and monitoring needs. Some general wellness wearables exist, but often lack the medical-grade data quality or raw data accessibility of Empatica's devices.
Physicians can access collected data through the Empatica Care Portal, a web-based dashboard designed for managing participants and monitoring digital biomarkers. The platform also offers a Cloud API to facilitate integration with existing clinical trial management software and potentially EHR systems, allowing for automated data transfer and simplified study management. This enables physicians to view and download data securely, enhancing trial efficiency and streamlining workflows.
Empatica Care utilizes the medical-grade EmbracePlus wearable, which is CE-certified and FDA-cleared as part of the Empatica Health Monitoring Platform, ensuring high data quality. The platform provides access to a vast range of raw sensor data and clinically validated digital biomarkers. Empatica has a proven track record in monitoring neurological conditions and developing AI-based predictive algorithms, with their technology trusted by leading research institutions and healthcare providers globally.

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