Care Portal
Secure online portal for managing studies, sites, and visualizing patient data
Company profile
Company profile
Empatica is a medical technology company specializing in wearable devices and digital biomarker platforms for remote patient monitoring and clinical research. Founded over a decade ago, the company has pioneered digital biomarker development in neurology, achieving the first FDA-cleared digital biomarker in the field. The Empatica Health Monitoring Platform combines award-winning medical-grade wearables (EmbracePlus and EmbraceMini) with sophisticated software and cloud infrastructure to collect clinical-quality physiological data from patients in real-world settings. The company's technology enables continuous monitoring of multiple physiological parameters including electrodermal activity (EDA), photoplethysmography (PPG), accelerometer, gyroscope, and temperature data. With over 300 digital measures available from a single wearable device, Empatica serves pharmaceutical companies, academic researchers, and healthcare providers across multiple therapeutic areas including epilepsy, Parkinson's disease, sleep disorders, and ADHD. Empatica holds 8 FDA clearances and CE MDR certification, with products deployed in over 160 countries and available in more than 40 languages. The company's technology has been referenced in over 12,000 research papers and is used by more than half of the top 20 pharmaceutical companies for clinical trials and digital endpoint development. The platform supports all phases of clinical trials with end-to-end remote monitoring capabilities, automated data collection, and real-time data transfer to secure cloud infrastructure. Empatica maintains ISO 13485 certification and operates from headquarters in Cambridge, Massachusetts, USA and Milano, Italy.
Company description Empatica Srl official website
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01 · Operating footprint
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
Api Only · Cloud Saas · Embedded deployment with recorded integration context.
Recorded integration context: CRO platforms, eCOA systems.
Company milestones
FDA clearance for EmbraceMini sleep monitoring (January 2026), CE MDR certification for Parkinson's Monitoring using PKG measures (January 2026), Partnership with DATALAND announced (2026), Launch of Parkinson's Monitoring solution combining PKG measures with Empatica wearables
Partnerships
02 · Flagship portfolio
Selected source-backed Company products and the available commercial context.
Secure online portal for managing studies, sites, and visualizing patient data
Direct API access to raw data and digital biomarkers from the Empatica Cloud
Electronic Clinical Outcome Assessment integration for richer, integrated trial data
Peace of mind epilepsy monitoring (no longer available for purchase)
The world's smallest actigraphy wearable for clinical trials and clinical care
The world's most advanced and versatile medical wearable with 5 powerful sensors
FDA-cleared full-stack health monitoring platform with medical-grade wearables and digital biomarkers
Next-generation epilepsy monitoring available in US, UK, EU, AU, NZ and CA
Modern, patient-friendly continuous tracking of motor symptoms and therapy response
03 · Research intelligence
Publications, preprints, clinical validation, and regulatory records in Evidence Position order.
Publications, clinical validation, and regulatory records connected to this Company appear here.
Research
Translational psychiatry · Nov 26, 2025
Flexible microfluidics-integrated electrochemical system for detection of tumor necrosis factor-alpha under continuous flow of sweat.Biosensors & bioelectronics · Nov 1, 2025
Multicenter Evaluation of Machine-Learning Continuous Pulse Rate Algorithm on Wrist-Worn Device.Digital biomarkers · Jan 1, 2024
ADHD Remote Technology study of cardiometabolic risk factors and medication adherence (ART-CARMA): a multi-centre prospective cohort study protocol.BMC psychiatry · Dec 20, 2022
Hyperexcitability in Cultured Cortical Neuron Networks from the G93A-SOD1 Amyotrophic Lateral Sclerosis Model Mouse and its Molecular Correlates.Neuroscience · Sep 15, 2019
Clinical validation
NCT04964609 · Sponsor · COMPLETED
Regulatory
K250515 · 510k · Jun 19, 2025
Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalK242737 · 510k · Jun 6, 2025
EpiMonitorK232915 · 510k · Feb 15, 2024
EmbraceK181861 · 510k · Dec 20, 2018
04 · Company-reported outcomes
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
Global deployment across patients and trial participants
Largest range of digital measures from a single wearable solution
Academic publications using or referencing Empatica technology
Global availability in over 40 languages
Monitoring adult ADHD and cardiometabolic conditions to develop ways to monitor symptoms and risks for optimized and personalized treatment approaches
Acquired new and unique real-world data using continuous health monitoring to contribute to optimized treatment approaches
Partnership with the world's first omni-sensory museum for health monitoring applications
Diagnosing and treating Obstructive Sleep Apnea (OSA) using machine learning approach with EmbracePlus to accurately diagnose OSA and provide optimal treatment
Brought together researchers and patients from across Europe under a single platform for OSA research
Creating a digital biomarker for Fabry Disease diagnosis by exploring correlation between Electrodermal Activity (EDA) and sweat patterns using EmbracePlus
Successfully created a digital biomarker for Fabry Disease, a rare genetic disorder causing absent or reduced sweating
05 · Leadership
Leadership profiles and professional links from the current Company record.
No active leadership profiles are currently listed.
06 · Company updates
Recent articles published on Empatica Srl's official website.
07 · HAIC coverage
Health AI Central reporting that mentions this Company.
No HAIC coverage is currently linked to this Company.
08 · Official presence
Curated official destinations from the active Company record.
09 · Market pathway
Other active Companies in the same market, selected alphabetically from the HAIC directory.
Market context
Companies providing AI-powered remote patient monitoring solutions, wearable health devices with AI analytics, continuous health tracking, or platforms that monitor patients outside clinical settings. Includes general wellness wearables with AI coaching, respiratory monitoring devices, and connected health platforms that aggregate and analyze physiological data from sensors.
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Linked research, clinical, and regulatory source pathways.
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Record-level provenance and review context.