Empatica
Empatica is a digital biomarker and wearable AI company that develops FDA-cleared medical wearables and a cloud health monitoring platform for pharmaceutical clinical trials, academic research, healthcare providers, and patients managing epilepsy and Parkinson's disease.
- Company typePrivate
- Founded2012
- HeadquartersCambridge, United States
- Headcount101–250
- GTM typeB2B and B2C
- OfferingHardware or Manufacturing
What Empatica does
Empatica is a digital biomarker and wearable AI company that develops FDA-cleared medical-grade wearables and a cloud-based health monitoring platform for pharmaceutical clinical trials, academic research, healthcare delivery, and direct patient care. Founded in 2011 and headquartered in Cambridge, Massachusetts with R&D operations in Milan, Italy, the company serves more than half of the top 20 global pharmaceutical companies alongside academic institutions, public health systems, government research agencies, and patient populations managing chronic neurological conditions including epilepsy and Parkinson's disease.
The product architecture centers on the Empatica Health Monitoring Platform, which integrates FDA-cleared hardware — the EmbracePlus smartwatch (PPG, EDA, accelerometer, gyroscope, temperature) and the EmbraceMini actigraphy device — with cloud infrastructure, software portals (Care Portal and Care Lab Portal), and a library of 300+ digital biomarkers derived from multi-sensor physiological data streams. The platform has secured 8 FDA 510(k) clearances, CE Mark certification as a Class IIa medical device, MDSAP certification, ISO 13485, and ISO/IEC 27001, and reports documented technical performance including 98% seizure detection accuracy against EEG gold-standards and 95%/88% sensitivity/specificity on Parkinson's bradykinesia scoring versus UPDRS III. The company expanded into Parkinson's disease monitoring through the October 2025 acquisition of PKG Health, integrating 30+ validated movement disorder algorithms into its wearable platform.
Empatica operates a hybrid revenue model combining hardware sales (EmbracePlus, EmbraceMini, EpiMonitor) with multi-year software subscriptions and enterprise clinical trial services. Distribution occurs through direct enterprise sales to pharmaceutical/biotech companies and CROs, an e-commerce storefront for academic research with 25% academic discount and automatic volume pricing from 5+ devices, and direct-to-consumer channels for the EpiMonitor epilepsy system (which requires a prescription in the US). Pricing for academic bundles ranges from $1,749.60 (3-year) to $2,187 (5-year), with custom enterprise pricing for pharmaceutical clients. The company reports its products are deployed in 160+ countries across 40+ languages, with 100,000+ devices shipped and 12,000+ peer-reviewed research publications referencing its technology.
Empatica firmographics
Firmographics- Name
- Empatica
- Legal name
- Empatica Inc.
- Website
- https://empatica.com
- Company type
- Private
- Founded year
- 2012
- Operating status
- Operating
- Headcount range
- 101–250 employees
- Short description
- Empatica is a digital biomarker and wearable AI company that develops FDA-cleared medical wearables and a cloud health monitoring platform for pharmaceutical clinical trials, academic research, healthcare providers, and patients managing epilepsy and Parkinson's disease.
- Ownership category
- akta.pro rank
Empatica industry classification
Industry- Product category
- Medical Wearables & Digital Health Monitoring
- NAICS
- Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Medical Equipment and Supplies Manufacturing (3391)
- SIC
- Surgical & Medical Instruments & Apparatus (3841), Services-Prepackaged Software (7372)
- akta.pro primary industry
- SaMD – Digital Biomarkers & Algorithmic Endpoints (HLACANAF)
- akta.pro secondary industry
- eCOA/ePRO/eDiary & Patient-Facing Data Collection (HLACAOAB)
Keywords
Where Empatica is headquartered
LocationHeadquarters
- HQ city
- Cambridge
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
Empatica business model
Business model- GTM type
- B2B and B2C
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Supply Chain, Operations, Marketing or Sales, Infrastructure, Others
Revenue model
- Medical Wearable Device Sales: Sale of FDA-cleared/CE-certified medical wearables including EmbracePlus, EmbraceMini, and EpiMonitor systems. Hardware devices are sold directly to consumers, healthcare providers, and research institutions with various form factors and accessories.
- Software Platform Subscriptions: Annual and multi-year subscriptions for access to Empatica Health Monitoring Platform including Cloud access, Care Portal, and digital biomarker analysis. Pricing includes 3-year and 5-year bundle options with automatic volume discounts from 5 devices and up.
- EpiMonitor Subscription Services: Monthly subscription plans for EpiMonitor users providing access to automated seizure alerts, data storage, and companion apps. Includes prescription requirement for US orders.
- Clinical Trial Services: B2B enterprise agreements with pharmaceutical companies and CROs for remote patient monitoring in clinical trials. Includes dedicated account management, regulatory support, and custom integration services.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Subscription | Multi-year contract | Academic Standard 3-Year Bundle |
| Subscription | Multi-year contract | Academic Standard 5-Year Bundle |
| Subscription | Monthly | EpiMonitor Consumer Plans |
| Subscription | Annual | Enterprise Clinical Trials |
Go-to-market motion2 records
Distribution channels5 records
Marketing channels6 records
Empatica product offering
Product offeringCore offering
Empatica develops and sells FDA-cleared, CE-certified medical wearables (EmbracePlus, EmbraceMini) combined with the Empatica Health Monitoring Platform — a cloud-based software suite that derives 300+ validated digital biomarkers from continuous physiological sensor data for use in clinical trials, academic research, epilepsy monitoring, and Parkinson's disease management.
Product overview
Empatica is a digital biomarker and wearable AI company offering a unified platform-plus-modules architecture centered on the Empatica Health Monitoring Platform. The core platform combines FDA-cleared/CE-certified wearables (EmbracePlus and EmbraceMini) with cloud infrastructure, software suites (Care App, Care Portal, Care Lab App/Portal), and over 300 digital biomarkers. Key product lines include: EpiMonitor for next-generation epilepsy monitoring; Parkinson's Monitoring (enhanced by acquired PKG Health algorithms) for movement disorder tracking; Actigraphy solutions for sleep and activity measurement; Aria for respiratory infection detection; Cloud API for Clinical Trials enabling data integration; and eCOA for clinical outcome assessment. The company serves pharmaceutical companies conducting clinical trials, academic researchers, healthcare providers, and patients managing chronic conditions.
Differentiator
Problem solved
Functional benefit
Brands
- EpiMonitor: Next-generation FDA-cleared epilepsy monitoring system with seizure detection and alerting capabilities
- Embrace2
- EmbracePlus
- EmbraceMini
- PKG Health
- Empatica Health Monitoring Platform
Products and services
- Empatica Health Monitoring Platform Full-stack, FDA-cleared remote health monitoring platform that combines EmbracePlus and EmbraceMini wearables with cloud infrastructure, software suite, and 300+ digital biomarkers for clinical trials and clinical care. Designed for pharmaceutical companies, biotech firms, CROs, academic institutions, and healthcare providers.
- EmbracePlus Flagship FDA-cleared and CE-certified medical-grade smartwatch with multi-sensor array (PPG, EDA, accelerometer, gyroscope, temperature), IP67 waterproofing, E Ink display, and up to 7 days battery life. Designed for continuous physiological monitoring in clinical trials and clinical care.
- EmbraceMini World's smallest FDA-cleared actigraphy wearable for clinical trials with accelerometer, gyroscope, magnetometer, ambient light sensor, 14+ days battery life, IP67 waterproofing, and modular design. FDA-cleared for sleep monitoring.
- EpiMonitor Next-generation FDA-cleared epilepsy monitoring system comprising EmbracePlus wearable and a companion smartphone app. Detects generalized tonic-clonic seizures lasting 20+ seconds with 98% accuracy, sends automated caregiver alerts, and tracks seizure diary, sleep, and activity. Available to consumers in the US, UK, EU, AU, NZ, and CA with a valid US prescription.
- Cloud API for Clinical Trials Cloud API that enables clinical trial sponsors and partners to integrate medical-grade data from EmbracePlus into existing healthcare infrastructure, with data available in raw format and as digital biomarkers in CSV format. Includes a plug-and-play SDK for building patient apps.
- Parkinson's Monitoring Continuous Parkinson's disease monitoring solution combining PKG Health's validated movement disorder algorithms (Bradykinesia Score, Dyskinesia Score, Tremor metrics) with Empatica's FDA-cleared, CE-certified wearables. Provides 38+ movement disorder measures and 200+ sleep and activity measures for clinical trials and clinical care.
- Aria Early detection and monitoring system for respiratory infections and COVID-19 that analyzes physiological signals collected by Empatica wearables to produce daily output on infection likelihood. Pluggable into the Empatica Health Monitoring Platform.
- eCOA Electronic Clinical Outcome Assessment module that integrates with the Empatica Health Monitoring Platform for richer, more integrated clinical outcome data collection in clinical trials.
Quantifiable outcome
- 98% seizure detection accuracy against gold-standard EEG measurement
- +5 more outcomes
Companies that use Empatica
Customer profileNamed customers9 records
Segments5 records
Ideal customer profiles6 records
Empatica technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- Yes
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability9 records
Feature5 records
Empatica partnerships and signals
Strategic signalPartnerships
Eight partnerships are on record, tiered core, minor and notable.
- PKG HealthcoreEmpatica acquired PKG Health to integrate its movement disorder algorithms for Parkinson's disease monitoring. This acquisition expands Empatica's capabilities in clinical care, neurology research, and diagnostics by combining PKG's validated PKG algorithms with Empatica's FDA-cleared wearable platform.
- DATALANDminorPartnership with DATALAND, described as the world's first omni-sensory museum, to explore applications of wearable technology in immersive museum experiences.
- DATAcc by DiMe (Digital Medicine Society)notableEmpatica is one of over 20 industry, advocacy, and research partners collaborating on DATAcc's development of the first digital measures specifically designed for common mental health disorders, including sleep regularity, physical activity, autonomic function, and other digital biomarkers.
- XtalksminorEmpatica participates as a speaker in Xtalks webinars focused on clinical trial topics, specifically discussing participant-site readiness for complex rare disease trials and leveraging wearable technology to streamline trial execution.
- NHS (UK National Health Service)notableNHS partnership for remote patient monitoring initiatives, demonstrating adoption of Empatica's health monitoring platform in a major healthcare system.
- EisainotablePartnership with Eisai pharmaceutical company for remote patient monitoring applications in healthcare delivery.
- NASA/TRISH (Translational Research Institute for Space Health)notableEmbracePlus developed as part of projects with NASA Human Research Program and US Army Medical Research and Development Command, indicating government and space agency validation of technology.
- DARPAnotableResearch collaboration with DARPA for advanced wearable technology development.
Scale indicators9 records
Recent moves6 records
Expansion highlights7 records
Empatica competitors and assessment
Company assessmentDirect peers
- ActiGraph: ActiGraph is a direct competitor in medical-grade wearable actigraphy devices and digital endpoints for clinical trials and academic research. Both companies target pharma, CROs, and academic institutions with FDA-cleared wearables and actigraphy-based measures, overlapping closely with Empatica's EmbraceMini and Health Monitoring Platform offerings.
- VivoSense: VivoSense develops wearable sensor-based digital biomarkers and regulatory-grade digital endpoints for clinical trials, directly competing with Empatica's pharma and CRO offering. Both companies focus on validated sensor data, regulatory submissions, and clinical outcome assessments for decentralized trials.
- Biofourmis: Biofourmis is a direct competitor in AI-enabled remote patient monitoring and digital therapeutics, providing wearable-driven continuous monitoring for clinical trials and care management. Both companies serve pharma/biotech clients with continuous physiological data, biomarker analytics, and FDA-aligned regulatory pathways.
Emerging players
- iRhythm Technologies: iRhythm is a digital health company with FDA-cleared wearable cardiac monitoring (Zio) producing continuous ECG-derived biomarkers. It is comparable to Empatica's continuous-monitoring approach in neurology/cardiology and overlaps in clinical trial cardiac endpoint use cases, though focused specifically on arrhythmia detection.
- Oura: Oura is a consumer wearable ring with continuous temperature, HR, HRV, and sleep tracking that has expanded into research collaborations and health monitoring partnerships. It is comparable to Empatica's continuous monitoring platform for general health and sleep, though Oura is consumer-focused while Empatica targets regulated clinical use cases.
- Whoop: Whoop is a consumer-grade continuous health wearable focused on recovery, sleep, and strain, and has expanded into research and B2B partnerships with health systems. It overlaps with Empatica's continuous monitoring and actigraphy use cases for general wellness and research, though lacking medical-grade regulatory clearances.
Broad incumbents
- Medidata (Dassault Systèmes): Medidata is a broad clinical trial technology incumbent whose eCOA, Rave, and decentralized trial platforms intersect with Empatica's eCOA module and Cloud API for Clinical Trials. Both serve pharma and CROs for clinical outcome data capture, with Medidata operating a much wider portfolio while Empatica differentiates through hardware-collected biomarkers.
- Clario: Clario is a broad clinical trial endpoint technology incumbent providing eCOA, cardiac safety, imaging, and digital biomarker solutions to pharma and CROs. It is comparable to Empatica's enterprise offering as an end-to-end trial data partner, though Clario operates across many modalities while Empatica focuses on wearable-collected digital biomarkers.
- Apple: Apple is a broad incumbent in consumer health wearables, with Apple Watch offering FDA-cleared ECG, AFib, and mobility features increasingly used in research-grade studies. Although not positioned as a clinical-grade platform, Apple's scale and ongoing health sensor additions shape sponsor expectations and competitive pressure on Empatica's pricing and adoption.
- Fitbit (Google): Fitbit, owned by Google, is a broad consumer wearable incumbent with health features and an active research device program used in clinical studies. Comparable to Empatica as an alternative wearable data source for large-scale observational and interventional studies, particularly where consumer scale and lower cost outweigh medical-grade validation.
Market position
Strengths4 records
Weaknesses5 records
Competitive moat5 records
Key risks7 records
Key highlights7 records
Customer concentration
Empatica social profiles
Digital presenceEmpatica compliance and trust
Trust signalCompliance7 records
Empatica financial estimates
Financial estimateRevenue estimate
Valuation estimate
Empatica leadership team
Management profileNumber of profiles
Profiles8 records
Empatica subsidiaries and ownership
Company hierarchySubsidiaries1 record
Empatica funding detail
Funding detailFunding overview
Funding rounds6 records
Investors8 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Empatica M&A and investment
M&A and investmentM&A1 record
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Empatica
What does Empatica do?
Empatica develops and sells FDA-cleared, CE-certified medical wearables (EmbracePlus, EmbraceMini) combined with the Empatica Health Monitoring Platform — a cloud-based software suite that derives 300+ validated digital biomarkers from continuous physiological sensor data for use in clinical trials, academic research, epilepsy monitoring, and Parkinson's disease management.
Is Empatica a public or private company?
Empatica is a private company. It is classified as venture growth investor backed and is currently operating.
When was Empatica founded?
Empatica was founded in 2012. It employs 101 to 250 people.
Where is Empatica based?
Empatica is headquartered in Cambridge, United States, in the North America region.
How does Empatica make money?
Four revenue lines are on record. Medical Wearable Device Sales are the primary driver. The others are software Platform Subscriptions, epiMonitor Subscription Services and clinical Trial Services.
Who are Empatica's main competitors?
Direct peers on record are ActiGraph, VivoSense and Biofourmis. Emerging players are iRhythm Technologies, Oura and Whoop. Broad incumbents are Medidata (Dassault Systèmes), Clario, Apple and Fitbit (Google).
Does Empatica have an API?
Yes. The Empatica Health Monitoring Platform offers a Cloud API for Clinical Trials, enabling integration of medical-grade data from EmbracePlus into existing healthcare infrastructure. The platform provides a plug-and-play SDK that allows developers to create patient apps which collect and stream EmbracePlus data to their infrastructure, with data available in both raw format and as digital biomarkers. Data is provided in CSV format for 1-minute digital biomarkers. The platform supports integration with EHR systems and healthcare provider infrastructure.
What industry is Empatica in?
Empatica's product category is Medical Wearables & Digital Health Monitoring. Its primary akta.pro industry code is HLACANAF, SaMD – Digital Biomarkers & Algorithmic Endpoints, with a secondary code of HLACAOAB, eCOA/ePRO/eDiary & Patient-Facing Data Collection. Its NAICS code is 334510 and its SIC code is 3841.