Empatica

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.

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

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

• Medical wearable devices
• Digital biomarkers
• Remote patient monitoring
• Clinical trial technology
• Wearable health monitoring

Headquarters

HQ city

Cambridge

HQ country

United States

HQ region

North America

Offices2 records

Markets served

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

1. 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.
2. 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.
3. 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.
4. 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

Go-to-market motion2 records

Distribution channels5 records

Marketing channels6 records

Core 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

Named customers9 records

Segments5 records

Ideal customer profiles6 records

Technology focussed Yes

API detail

Has API

Yes

API docs

API detail

Core technology

AI maturity

App detail

AI capability9 records

Feature5 records

Partnerships

Eight partnerships are on record, tiered core, minor and notable.

• PKG HealthcoreStrategic or Co-development Partner · 7 October 2025Empatica 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.
• DATALANDminorStrategic or Co-development PartnerPartnership 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)notableStrategic or Co-development PartnerEmpatica 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.
• XtalksminorGTM or Marketing PartnerEmpatica 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)notableStrategic or Co-development PartnerNHS partnership for remote patient monitoring initiatives, demonstrating adoption of Empatica's health monitoring platform in a major healthcare system.
• EisainotableStrategic or Co-development PartnerPartnership with Eisai pharmaceutical company for remote patient monitoring applications in healthcare delivery.
• NASA/TRISH (Translational Research Institute for Space Health)notableStrategic or Co-development PartnerEmbracePlus 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.
• DARPAnotableStrategic or Co-development PartnerResearch collaboration with DARPA for advanced wearable technology development.

Scale indicators9 records

Recent moves6 records

Expansion highlights7 records

Direct 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

• Xx.com/empatica
• YouTubeyoutube.com/empatica
• Facebookfacebook.com/empatica
• LinkedInlinkedin.com/company/empatica
• Instagraminstagram.com/empatica_wearables

Compliance7 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Subsidiaries1 record

Funding overview

Funding rounds6 records

Investors8 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Empatica