Empatica Health Monitoring Platform

by Empatica  · Based in United States → — Medical devices, AI and algorithms for remote patient monitoring
Cardiology Neurology Sleep Medicine
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Starts at $0.33/day for basic plans, with academic bundles available. specific pricing for the health monitoring platform for clinical trials and larger deployments requires direct contact.
Regulatory Status Disclosed

Overview

Empatica Health Monitoring Platform is a comprehensive, full-stack digital health solution designed for continuous physiological monitoring and data analysis. Built on medical-grade wearable devices like EmbracePlus and EmbraceMini, it integrates a dedicated software suite (Care Lab App, Care Portal) and secure cloud infrastructure. The platform enables researchers, healthcare organizations, and clinical trial sponsors to collect and analyze a wide range of physiological signals, including electrodermal activity (EDA), heart rate (HR), heart rate variability (HRV), movement, skin temperature, blood oxygen saturation (SpO2), and respiratory rate. It provides access to both raw data and clinically validated digital biomarkers, supporting remote patient monitoring, decentralized clinical trials, and advanced clinical research across various therapeutic areas.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Medical-grade wearable devices (EmbracePlus, EmbraceMini)
  • Continuous physiological data collection (EDA, PPG, Accelerometer, Temperature, SpO2, Pulse Rate, Respiratory Rate)
  • Clinically validated digital biomarkers (300+ research-grade, 6 FDA-cleared)
  • Cloud-based data storage and management (Empatica Cloud, Care Portal)
  • Mobile app for data transfer (Care Lab App/Patient App)
  • Raw data access and export (CSV, Avro)
  • Remote study setup and management
  • Scalable for clinical trials and academic research
  • API for integration with existing systems (CTMS, EHR)
  • Long battery life (EmbracePlus up to 28 days)

Use Cases

  • Clinical Trials (decentralized, hybrid)
  • Academic Research
  • Remote Patient Monitoring
  • Parkinson's & Movement Disorders Monitoring
  • Epilepsy Monitoring (via EpiMonitor, part of the platform)
  • Actigraphy (sleep and physical activity)

What Physicians Need to Know

Evidence Base
The Empatica Health Monitoring Platform leverages continuous, high-frequency raw data from EmbracePlus sensors, including PPG, EDA, Skin Thermometer, and Accelerometer data. It provides over 300 digital biomarkers, including algorithms from partners like McRoberts, Mobilise-D, and PKG Health. The platform is used in clinical trials and academic research across various therapeutic areas, with thousands of publications made possible by Empatica's technology. Empatica also offers eCOA (electronic Clinical Outcome Assessment) capabilities, integrating ePROs (patient-reported outcomes), functional tests, and medication reminders with digital measures.
Clinical Validation Studies
The Empatica Health Monitoring Platform is FDA-cleared and CE-certified. Its algorithms for digital biomarkers, including SpO2, EDA, skin temperature, and movement during sleep, have been validated against gold standards in clinical studies with diverse participant groups. The platform is used in over 120 industry-sponsored trials. Empatica validates its regulated products according to regulatory requirements and industry standards like GAMP 5. Research using Empatica's PKG algorithms in Parkinson's treatment planning showed a 33% improvement in predicting optimal medication regimens, reaching 86.9% accuracy.
Drug Interaction Checking
The Empatica Health Monitoring Platform does not explicitly offer drug interaction checking. However, its eCOA capabilities include medication reminders and adherence tracking, allowing patients to log when medications are taken or skipped, which can be reviewed by healthcare professionals.
Differential Diagnosis Support
The Empatica Health Monitoring Platform is not intended for diagnostic purposes or to be used as the sole basis for clinical decision-making. It provides physiological data and digital biomarkers for retrospective review by trained healthcare professionals or researchers.
Clinical Workflow Integration
The Empatica Health Monitoring Platform can be integrated into existing clinical trial management systems (CTMS) and electronic health record (EHR) systems through Cloud APIs and SDKs. This allows for seamless data flow, participant management, and direct data integration into existing infrastructures. The platform supports remote patient monitoring and can be used to triage patients with data-driven insights.
Decision Audit Trail
The Empatica Health Monitoring Platform is designed to meet regulatory standards for clinical trials, including compliance with 21 CFR Part 11, HIPAA, and GDPR. It generates complete audit trails for data and system activities, supporting regulatory submissions and quality audits.
Physician Tip

Physicians should utilize the Empatica Health Monitoring Platform for retrospective analysis of physiological parameters and digital biomarkers to gain objective insights into patient health trends and treatment responses. It is crucial to remember that the platform is not intended for real-time alerts or as the sole basis for clinical decision-making. Integrate the collected data with other clinical information and professional judgment for comprehensive patient management. The platform's ability to provide continuous, real-world data can be particularly useful for monitoring chronic conditions, assessing treatment efficacy, and supporting personalized care plans, especially in areas like Parkinson's disease management.

The Empatica Health Monitoring Platform offers robust integration capabilities through its Cloud APIs and SDK. This allows for seamless integration with existing clinical trial management systems (CTMS), electronic data capture (EDC) platforms, and electronic health record (EHR) systems. Data can be transferred directly to your preferred cloud infrastructure, enabling efficient data management and analysis within your current workflows. The platform also supports the integration of eCOA modules, including ePROs and functional tests, within its Care App, streamlining data collection from participants.

Details

Category Clinical Decision Support & Reference, Drug Discovery & Research, Wearables & Remote Monitoring (RPM)
Pricing Starts at $0.33/day for basic plans, with academic bundles available. specific pricing for the health monitoring platform for clinical trials and larger deployments requires direct contact.
Free TrialUnknown
DeploymentCloud-based. Data is transmitted from wearable devices via a mobile app to the Empatica Cloud.
Mobile AppYes, the 'Care App' is used by patients and trial participants to collect and transmit data from Empatica wearables to the cloud.
API AvailableUnknown
Data ExportUnknown
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated
GDPR Yes AI-estimated
Integrations
EHR Not specified
Specialties Cardiology, Neurology, Sleep Medicine

What the Web Says

The Empatica Health Monitoring Platform provides a comprehensive remote patient monitoring and research solution using medical-grade wearables to collect physiological data. It boasts FDA clearance for continuous monitoring of various biomarkers and integrates with existing healthcare systems. While effective for seizure detection and Parkinson's monitoring, some users have noted connectivity issues, false positives, and app-related battery drain.

Overall: Mixed

Strengths

  • Continuous, remote monitoring of physiological parameters in home and healthcare environments.
  • FDA-cleared for continuous data collection of electrodermal activity, skin temperature, SpO2, movement during sleep, pulse rate, and respiratory rate.
  • Offers a plug-and-play SDK for easy integration of medical-grade data into existing infrastructure and EHRs.
  • Supports over 300 digital measures and clinically-validated physiological and behavioral digital biomarkers for research.
  • Effective in seizure detection and provides alerts to caregivers.
  • New features like double-device monitoring enhance data collection versatility for clinical trials.

Limitations

  • Some users report frequent false positives in seizure detection.
  • Connectivity issues between the wearable and the phone, even when in close proximity.
  • The companion app can significantly drain phone battery.
  • Lack of a robust caregiver view or cloud portal for parents to easily access data and trends.
  • Concerns about the cost of monthly subscriptions and insurance coverage.
  • Older models (Embrace) had issues with continuous monitoring, poor battery life, and slow customer service.

Based on reviews from: empatica.com, reddit.com, mpo-mag.com, prnewswire.co.uk, featuredcustomers.com, sleepreviewmag.com, fda.gov, wikipedia.org, apple.com, google.com

Last updated: 2026-10-29

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Press & Coverage

Empatica
Empatica Acquires PKG Health to Transform Parkinson's Disease Monitoring
Empatica acquired PKG Health in October 2025, integrating PKG Health's validated algorithms for movement disorder monitoring into Empatica's FDA-cleared wearable technology and health monitoring platform. This acquisition aims to broaden Empatica's reach in neurology research, clinical care, and diagnostics, particularly for Parkinson's disease.
2025-10
Empatica
Empatica Receives FDA Clearance for Parkinson's Monitoring
Empatica announced in August 2026 that its Health Monitoring Platform for Parkinson's received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This clearance allows for continuous symptom monitoring and provides objective data to support personalized care for Parkinson's patients at home.
2026-08
PR Newswire
Empatica launches WellPD, an FDA-cleared Parkinson's monitoring device for home use.
Empatica launched WellPD in October 2026, an FDA-cleared and CE-marked wearable device and companion app for people with Parkinson's to monitor their symptoms at home. WellPD tracks motor symptoms like tremor, dyskinesia, bradykinesia, as well as sleep and activity.
2026-10
Empatica
FDA Clears Empatica's EmbraceMini for Sleep Monitoring
In January 2026, Empatica announced that EmbraceMini received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for sleep monitoring. This establishes EmbraceMini as a medical-grade wearable for remote health monitoring, enabling healthcare professionals and researchers to assess sleep and circadian rhythms.
2026-01
Empatica
The Empatica Health Monitoring Platform receives FDA-clearance
Empatica announced in November 2022 the FDA clearance of its Health Monitoring Platform, a full-stack remote health monitoring and data collection solution for research and healthcare professionals. The platform is built on data collected by the EmbracePlus wearable and includes Empatica's Care software suite, cloud infrastructure, and clinically validated digital biomarkers.
2022-11
Empatica
Empatica's Platform Receives New FDA Clearance for Cardiac Digital Biomarkers
In November 2023, Empatica received FDA 510(k) clearance for two new digital biomarkers for its Health Monitoring Platform: pulse and respiratory rate. This addition brings the total to six FDA-cleared digital biomarkers available on the platform for use in clinical trials.
2023-11
Empatica
Empatica Health Monitoring Platform for Parkinson's
The Empatica Health Monitoring Platform for Parkinson's enhances care with objective, continuous monitoring and clinical-grade insights, utilizing PKG-based measures from patients' homes. It combines PKG's validated motor assessments with Empatica's FDA-cleared and CE MDR certified wearable technology.
unknown
Empatica
Empatica Health Monitoring Platform
The Empatica Health Monitoring Platform is a comprehensive solution for continuous, remote monitoring of patient physiology in home and healthcare environments. It combines an award-winning wearable, continuous data collection, and access to raw sensor data and clinically validated digital biomarkers.
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Videos

Product demos, reviews, and walkthroughs for Empatica Health Monitoring Platform.

View all on YouTube

Frequently Asked Questions

The Empatica Health Monitoring Platform provides continuous, real-world health insights using FDA-cleared wearables like EmbracePlus and EmbraceMini. It collects raw data and digital biomarkers, which can be integrated into existing healthcare provider infrastructure and EHRs. This data helps clinicians monitor patient physiology, understand treatment response, and make more informed, personalized treatment decisions, particularly in areas like Parkinson's disease and epilepsy.
The platform aims to enhance patient participation with user-friendly wearables, automated data collection, and in-app troubleshooting. Features like long battery life (up to 28 days for EmbracePlus) and self-troubleshooting within the app contribute to better compliance. Empatica also provides compliance dashboards and real-time data access for study teams to identify and address compliance issues promptly.
The Empatica Health Monitoring Platform has several limitations. It is not intended to predict seizure onset, be used during physical activity, or guide medical therapy decisions as a standalone monitoring device. It is also not for use in acutely ill cardiac patients, high-acuity environments like ICUs, or for diagnostic purposes. Additionally, it does not detect every seizure type, and its SpO2 monitoring is not intended for conditions of high motion or low perfusion.
Yes, there are several alternatives for remote patient monitoring. These include platforms like CareSimple, HealthArc, and Medable, which offer various features such as HIPAA-compliant data capture, EHR integration, and automated tracking of CMS RPM billing codes. Other solutions, like NightWatch+, offer different approaches to monitoring, particularly for conditions like epilepsy, with varying hardware and subscription models.
Empatica's platform is designed to meet regulatory standards for clinical trials. Its devices, EmbracePlus and EmbraceMini, are FDA-cleared and CE MDR certified. Data storage and transmission comply with 21 CFR Part 11, HIPAA, and GDPR. The platform also generates complete audit trails, supports IRB submissions, and undergoes regular independent quality audits to ensure data security and integrity.
While specific pricing for healthcare providers is typically arranged through quotations, Empatica offers bundles for its devices and platform access. For example, an EmbracePlus device with 5 years of data access and portal access is priced around $2187, and an EmbraceMini with similar access for 5 years is around $1465.29. There are also subscription plans for specific monitoring solutions like EpiMonitor, which have different tiers and annual options.

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

Investors who backed Empatica Health Monitoring Platform

Funded through the company that built this tool.

Sanofi Ventures
Corporate VC AI T1
Cambridge, United States
$5M-$25M
Sanofi Ventures is the strategic investing arm of one of the world’s largest pharmaceutical companies, and it operates with the patience and…
AI/ML in Healthcare Biotech
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