Products

Embrace
Empatica Srl
Neurology AI
Embrace by Empatica is an AI-powered wearable biosensor device for seizure monitoring in individuals with epilepsy, detecting generalized tonic-clonic seizures and alerting caregivers. It also tracks sleep, rest, and physical activity.
EpiMonitor
Empatica Srl
Neurology AI
EpiMonitor by Empatica is an FDA-cleared wearable medical device system for epilepsy monitoring and seizure detection, providing automated seizure alerts to caregivers, a comprehensive seizure diary, and health tracking.

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About Empatica Srl

Empatica Srl, an MIT spin-off, is a digital health company specializing in medical-grade wearables and an AI-driven platform for continuous health monitoring and the early detection of medical conditions. Their technology focuses on developing and deploying digital biomarkers by collecting physiological signals such as heart rate, electrodermal activity (EDA), skin temperature, and movement. The Empatica Health Monitoring Platform, featuring FDA-cleared and CE-certified wearables like EmbracePlus and EmbraceMini, enables remote patient monitoring and supports decentralized clinical trials.

The platform is designed to provide real-time human insight for thousands of patients, clinicians, and researchers globally. It offers a comprehensive suite of validated digital measures, allowing for the collection and analysis of high-quality, objective data in various therapeutic areas. Empatica’s solutions are utilized by major pharmaceutical companies for developing digital biomarkers as endpoints in clinical trials and by healthcare providers for personalized patient care, including recent advancements in Parkinson’s monitoring.

Focus Areas

Digital biomarker development continuous health monitoring remote patient monitoring decentralized clinical trials neurological conditions epilepsy monitoring Parkinson's monitoring movement disorders sleep monitoring stress monitoring activity tracking respiratory infections detection

Business Intelligence

Key InvestorsRA Capital Management, Sanofi Ventures, Black Opal Ventures, CDP Venture Capital, Innogest Capital, Europa
PartnershipsMcRoberts, Allucent (for PROJECT REMOTE with BARDA/HHS), NASA's Human Research Program (TRISH)
AcquisitionsPKG Health (October 2025), Global Kinetics Pty Ltd (October 2025)
TechnologyEmpatica Health Monitoring Platform (full-stack, AI and sensor-based, cloud-native, digital biomarkers, wearable devices like EmbracePlus and EmbraceMini, Cloud API)
FDA Clearances6 cleared products (estimated)

What Physicians Need to Know

Digital Biomarker Development
Empatica is a pioneer in developing clinically-validated and research-grade digital biomarkers, offering the world's largest selection with over 300 measures. They have achieved the first FDA-cleared digital biomarker in neurology and hold multiple FDA 510(k) clearances for various physiological measures, including pulse, respiratory rate, electrodermal activity, SpO2, skin temperature, and movement during sleep.
Continuous Health Monitoring
Their full-stack Empatica Health Monitoring Platform enables continuous, unobtrusive, and medical-grade health insights from real-world settings. This AI-enabled platform leverages wearable devices like EmbracePlus and EmbraceMini to collect raw physiological data and derive digital biomarkers.
Remote Patient Monitoring (RPM)
Empatica's platform, including the Care Portal, is designed for scalable remote patient monitoring, providing real-time insights into patient physiology from their homes. This reduces the burden on healthcare facilities and workers while enhancing the quality of care.
Decentralized Clinical Trials (DCT)
Empatica offers an end-to-end solution for decentralized clinical trials, streamlining data collection, reducing patient and site burden, and integrating eCOA (electronic Clinical Outcome Assessment) for comprehensive data capture. The platform is globally ready with multi-language support.
Neurological Conditions Monitoring
Empatica is a leader in monitoring neurological conditions. Their EpiMonitor system (powered by EmbracePlus) is an FDA-cleared epilepsy monitoring system for convulsive seizure detection. For Parkinson's disease and movement disorders, they offer CE MDR certified monitoring, incorporating validated PKG Health algorithms for objective measures like bradykinesia, dyskinesia, tremor, and gait.
Sleep & Activity Monitoring
The EmbraceMini is FDA-cleared for sleep monitoring and actigraphy, providing continuous, objective tracking of sleep-wake patterns and physical activity. Their validated sleep algorithms, benchmarked against polysomnography (PSG), enable detailed circadian rhythm analysis.
Stress Monitoring
The platform monitors autonomic stress by measuring electrodermal activity (EDA), providing insights into physiological responses.
Respiratory Infections Detection
Empatica's CE-certified Aura system (and Aria) provides early and pre-symptomatic detection of respiratory infections, including COVID-19, by analyzing vital signs against individual baselines using AI-based predictive algorithms.
Physician Tip

For physicians, Empatica Srl stands out due to its commitment to providing **clinical-grade, FDA-cleared, and CE-certified medical devices and digital biomarkers**, ensuring the reliability and accuracy of collected data for informed clinical decision-making. The **comprehensive and continuous real-world patient insights** across a wide range of physiological parameters and conditions (e.g., epilepsy, Parkinson's, sleep, respiratory infections) enable a holistic view of patient health beyond episodic clinic visits. The capability for **early detection and potential seizure forecasting or pre-symptomatic respiratory infection alerts** allows for timely interventions, potentially improving patient outcomes and preventing complications. Furthermore, the **Empatica Health Monitoring Platform reduces the burden on healthcare systems** by facilitating remote monitoring of thousands of patients simultaneously and streamlining data collection in clinical trials, leading to enhanced efficiency and support for personalized care. The **patient-friendly, unobtrusive wearables** with long battery life and intuitive apps also contribute to higher patient compliance and engagement, crucial for long-term monitoring.

Empatica's Health Monitoring Platform is designed for flexibility and integration. It offers a **Cloud API** for clinical trial sponsors and CROs to directly embed Empatica's wearable technology and data into their existing Clinical Trial Management Systems (CTMS) or other cloud infrastructures. The platform also supports **eCOA (electronic Clinical Outcome Assessment)**, allowing for the integration of patient-reported outcomes, functional tests, and medication reminders directly within the patient app, enriching data collection with both subjective and objective measures. Empatica's devices use **Bluetooth** to send data to a dedicated mobile app, which then transfers data to the Empatica Cloud via the internet. They also integrate algorithms from partners like McRoberts, Mobilise-D, and PKG Health to expand their digital biomarker offerings.

Products by Empatica Srl

2 products in the directory

Embrace
Empatica Srl
Neurology AI
Embrace by Empatica is an AI-powered wearable biosensor device for seizure monitoring in individuals with epilepsy, detecting generalized tonic-clonic seizures and alerting caregivers. It also tracks sleep, rest, and physical activity.
EpiMonitor
Empatica Srl
Neurology AI
EpiMonitor by Empatica is an FDA-cleared wearable medical device system for epilepsy monitoring and seizure detection, providing automated seizure alerts to caregivers, a comprehensive seizure diary, and health tracking.

What the Web Says

Empatica Srl develops AI-enabled wearable devices and software for health monitoring, particularly in research and clinical trials for conditions like epilepsy and Parkinson's. Their products, such as the Empatica E4 and EmbracePlus, are used to collect physiological data like electrodermal activity (EDA), blood volume pulse (BVP), and temperature. While praised for their research utility and the company's mission-driven culture, there are significant concerns regarding product reliability, customer service, and pricing models.

Overall: Mixed

Strengths

  • Products are good for research purposes, collecting various physiological data.
  • Empatica E4 is considered reliable for detecting EDA and cardiac activity in research settings.
  • The company is mission-driven with a focus on improving lives.
  • Positive work environment with smart, collaborative, and empathetic colleagues.
  • Opportunities for professional growth and cross-functional impact within the company.
  • Leadership team is described as smart, humble, respectful, and open to feedback.

Limitations

  • High cost of devices and expensive monthly subscription fees for full functionality, especially for seizure detection.
  • Frequent false alerts and missed actual seizure detections reported by users.
  • Poor and unresponsive customer service.
  • Issues with device connectivity (Bluetooth) and battery life.
  • Product design flaws, such as a poorly designed clock face and non-replaceable, hard-to-clean bands.
  • Lack of clear instructions for data extraction and limited real-time logging capabilities with some apps.

Based on reviews from: ResearchGate, Reddit, MDPI, Indeed.com, Trustpilot, Empatica, Comparably

Last updated: 2026-07-20

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Press & Coverage

Empatica Blog
Empatica receives landmark FDA PCCP authorization for pulse oximetry
Empatica announced that its pulse oximetry (SpO2) algorithm received the first-ever Predetermined Change Control Plan (PCCP) authorization from the U.S. FDA, allowing for algorithm updates without new 510(k) submissions.
2025-06
Business Wire
Empatica Achieves CE MDR Certification for EpiMonitor, Bringing Round-the-Clock Epilepsy Monitoring to Europe
Empatica's EpiMonitor, an epilepsy monitoring solution, has received CE MDR certification, making it available in Europe after its successful US launch and FDA clearance.
2025-05
Empatica Blog
Empatica Acquires PKG Health to Transform Parkinson's Disease Monitoring
Empatica acquired PKG Health, a company specializing in movement disorder algorithms for Parkinson's disease, to enhance its wearable technology and health monitoring platform.
2025-10
Signalbase
Empatica Secures $25 Million in Series B Funding for Cutting-Edge Wearable Health Technology
Empatica raised $25 million in Series B funding to advance its wearable devices and expand into new markets, including healthcare and wellness.
2024-10
Empatica Blog
Empatica Receives European MDR Certification for Health Monitoring Platform
Empatica's Health Monitoring Platform received CE Mark Certification under the EU's Medical Device Regulation (MDR), making it the largest wearable and digital biomarker solution with both CE MDR and FDA clearance.
2024-12
Empatica Blog
Empatica Announces Plans for Landmark Clinical Study to Develop an AI-Based Seizure Forecast Based on Wearable Real-World Data
Empatica is launching a clinical study to develop an AI-based algorithm for predicting refractory seizures using real-world data from its wearable technology.
2023-12
PR Newswire
Empatica receives new FDA clearance for its Health Monitoring Platform and announces Series B financing
Empatica announced FDA clearance for its Health Monitoring Platform for continuous monitoring of SpO2, Electrodermal Activity, Skin Temperature, and sleep movement, alongside Series B financing.
2022-11
Empatica Blog
FDA Clears Empatica's EmbraceMini for Sleep Monitoring
Empatica's EmbraceMini, a compact wearable, received 510(k) clearance from the FDA for sleep monitoring and broader physical activity analysis in clinical research and care.
2026-01

Frequently Asked Questions

Empatica's Health Monitoring Platform, featuring medical-grade wearables like EmbracePlus and EmbraceMini, provides continuous physiological data collection for digital biomarker development. For epilepsy, devices like Embrace2 and EpiMonitor are FDA-cleared for tonic-clonic seizure detection. Following the acquisition of PKG Health, Empatica now offers clinically validated algorithms for Parkinson's disease, enabling objective monitoring of motor symptoms such as bradykinesia, dyskinesia, and tremors.
Empatica's core offering is the Empatica Health Monitoring Platform, a full-stack solution that integrates medical-grade wearables (EmbracePlus, EmbraceMini) with a secure cloud infrastructure and software suite (Care Portal). This platform enables continuous, remote collection of physiological data and digital biomarkers, streamlining data collection for RPM. It significantly enhances the efficiency and scalability of decentralized clinical trials by reducing patient and site burden.
Empatica's Health Monitoring Platform and devices like EmbracePlus and EmbraceMini have received multiple FDA 510(k) clearances for various digital biomarkers, including SpO2, EDA, skin temperature, movement during sleep, pulse, and respiratory rate. The company also holds CE marks for its products, including for early detection of respiratory infections with Aria. Empatica ensures data privacy and security through HIPAA and GDPR compliance, implementing physical, electronic, and organizational procedures, including ISO/IEC 27001:2022 certification for information security.
Empatica's wearables and platform offer comprehensive monitoring capabilities, including FDA-cleared digital biomarkers for sleep detection, actigraphy for activity tracking, and skin temperature. Electrodermal Activity (EDA) is continuously monitored, providing insights into autonomic nervous system activity relevant to stress. Furthermore, Empatica's Aria system has received a CE mark for the early detection of respiratory infections, including COVID-19, by analyzing physiological signals.
The Empatica Health Monitoring Platform offers a plug-and-play SDK and Cloud API, allowing seamless integration of medical-grade data and digital biomarkers into existing healthcare provider infrastructures, EHRs, and clinical trial management systems. Empatica provides dedicated account management and support teams, along with patient and site materials, to facilitate implementation and ensure compliance. Key partners include government agencies like HHS and USAMRDC, research institutions such as Stanford and King's College London, and pharmaceutical companies like Eisai.
While specific pricing details are not publicly disclosed, Empatica offers plans for both large-scale decentralized clinical trials and smaller academic studies, with academic discounts available. Empatica, an MIT Media Lab spinoff, demonstrates stability through its multiple FDA clearances, CE certifications, global deployment in over 160 countries with 100,000+ devices, and strategic acquisitions like PKG Health, solidifying its leadership in digital biomarker development and remote patient monitoring.

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