8 Wearable Device Providers for Clinical Trials in 2026

A clinical trial wearables provider builds the sensors, smartwatches, patches, or smart garments that collect continuous, objective physiological or movement data from trial participants outside of scheduled clinic visits. This kind of wearable device service ranges from raw accelerometers built for actigraphy research, to medical-grade smartwatches cleared by the FDA for specific clinical uses, to smart clothing that captures a full range of vital signs, giving researchers real-world data that traditional point-in-time clinic assessments can't.

The wearable device providers below are listed in no particular order. Between them, these companies and providers cover raw-data actigraphy devices, medical-grade smartwatches, wearable hemodynamic and cardiac monitors, smart garments, and digital biomarker platforms built around wearable-collected data.

Activinsights

Activinsights built GENEActiv, a wrist-worn triaxial accelerometer the company launched more than 15 years ago as the first dedicated raw-data wearable of its kind, and the device has since been validated in more than 1,500 scientific publications and used in over 200 clinical trials across more than 20 therapeutic areas. Based in Kimbolton, England, the company's device captures unfiltered, high-resolution acceleration data sensitive enough to detect fine motor movements like tremor and scratching, giving researchers raw data they can reanalyze with new algorithms even after a study concludes. GENEActiv holds FDA 510(k) exemption status and EU CE marking, and can run continuously for up to two months without recharging, reducing the burden on both participants and site staff. Activinsights also offers the ActivInsights Band for shorter-duration studies and provides data analysis services that convert raw wearable output into digital measures usable as clinical trial endpoints.

Ametris

Ametris, known for two decades as ActiGraph, rebranded in June 2025 to reflect its evolution from a wearable device manufacturer into an end-to-end clinical trials platform spanning device-based data collection, AI-powered analytics, regulatory science, and operational support. Founded in 2004 in Pensacola, Florida, the company's wearable lineup, including the CentrePoint Insight Watch and ActiGraph LEAP, retained the ActiGraph brand name to preserve continuity across the extensive scientific literature and regulatory documentation built around the devices. Healthcare private equity firm ARCHIMED acquired a majority stake in the company in 2020, and in January 2025 the company acquired Biofourmis Connect before eClinical company Signant Health acquired Ametris outright, making it “A Signant Health Company.” The CentrePoint Insight Watch is an FDA-cleared Class II medical device in the US that captures raw acceleration data at up to 256 Hz for more than 30 days between charges.

Caretaker Medical

Caretaker Medical was founded in March 2014 to commercialize wireless monitoring devices built around its patented Pulse Decomposition Analysis (PDA) technology, which uses a small finger cuff to measure continuous, non-invasive blood pressure and hemodynamics without the arterial lines typically required for that level of monitoring precision. The company's flagship VitalStream platform has received five FDA clearances, most recently for cardiac output, stroke volume, heart rate variability, and left ventricular ejection time, and the Anesthesia Patient Safety Foundation has recommended PDA technology for its accuracy in beat-by-beat measurement. VitalStream has been used in published clinical trials comparing its non-invasive measurements against invasive arterial-line and Swan-Ganz catheter references across pediatric surgery and cardiac surgery ICU populations, with results supporting its equivalence to more invasive methods. The company, based in Charlottesville, Virginia, positions VitalStream as the only wireless, wearable ICU-grade continuous blood pressure and cardiac output monitor to be both clinically validated and FDA-cleared.

Empatica

Empatica launched in 2013 as a spinout of MIT's Media Lab and became the first company to have a smartwatch cleared by the FDA for a neurology application, when its Embrace device received clearance in 2018 for detecting generalized tonic-clonic seizures in epilepsy patients. The company's current flagship, EmbracePlus, has been used to monitor thousands of participants across hundreds of clinical trials, and its companion EmbraceMini device received FDA 510(k) clearance for sleep monitoring and actigraphy in early 2026. Empatica's Health Monitoring Platform is FDA-cleared and CE MDR certified, with all data managed in compliance with 21 CFR Part 11, HIPAA, and GDPR, and the company reports a greater than 90 percent compliance rate across its actigraphy studies. Key partners on Empatica's device development have included the US Department of Health and Human Services, the Army's USAMRDC, and NASA-funded TRISH, reflecting research uses spanning stress, sleep, epilepsy, migraine, depression, and addiction.

Great Lakes NeuroTechnologies

Great Lakes NeuroTechnologies (GLNT) manufactures the Kinesia family of wearable sensor products, an FDA-cleared, patented technology that has become an industry standard for objectively measuring movement disorder symptoms including tremor, slowness, and dyskinesia in Parkinson's disease and essential tremor research. The Cleveland, Ohio-based company built Kinesia 360 for continuous, ambulatory symptom monitoring throughout a patient's day using wireless sensors and a smartphone app, and later added KinesiaU, a smartwatch-based system patients can use to track their own symptoms and share reports with clinicians. GLNT's biomedical research team has presented multiple validation studies at the International Congress of Parkinson's Disease and Movement Disorders, demonstrating that clinicians with access to Kinesia sensor data made different treatment decisions, including advanced therapy referrals, than they would have without the objective data. The company also manufactures the BioRadio data acquisition system, used more broadly in physiological research and education settings beyond movement disorders.

Hexoskin

Hexoskin has developed sensor-embedded smart garments since 2006, evolving from health-monitoring shirts for cardiology and respiratory research into Astroskin, a space-grade bio-monitoring system now deployed aboard the International Space Station in partnership with NASA, the Canadian Space Agency, ESA, and JAXA. The Montreal-based company's Hexoskin Medical System is FDA-cleared for continuous, long-term ECG, respiratory, and activity monitoring, positioning it as a remote monitoring solution for chronic cardiopulmonary conditions like COPD and atrial fibrillation, alongside its use as a digital biomarker platform in cardiovascular, respiratory, and rare disease clinical trials. Customers and research partners, including NASA, the Department of Defense, Yale Health, and Columbia University, have published more than 250 scientific papers using Hexoskin data. CEO and co-founder Pierre-Alexandre Fournier has overseen the company's expansion of its Astroskin technology toward Gateway, the lunar space station expected to launch its first elements in 2027.

Koneksa Health

Koneksa Health builds validated digital biomarkers that translate data from wearables, smartphones, and patient-reported tools into regulatory-grade measurements usable as clinical trial endpoints, positioning itself as a measurement-science partner rather than solely a device maker. The New York-based company has developed digital biomarker programs across neuroscience, oncology, respiratory, and cardiovascular indications, including wearable-based motor tracking for Parkinson's disease and multiple sclerosis developed in partnership with Sanofi, and a mobile spirometry validation program with Regeneron. Koneksa raised a $45 million Series C round in 2022 to accelerate its digital biomarker platform, and in 2026 launched Lodestar, an AI-assisted regulatory and biometrics workflow tool aimed at eliminating fragmentation in submission pipelines. The company has partnered with the Michael J. Fox Foundation and Northwestern University on speech-based digital biomarkers for Parkinson's disease and has published more than 20 peer-reviewed papers on its measurement approaches.

Verisense Health

Verisense Health launched in January 2023 as a spin-off of Shimmer Research, a Dublin-based wearable sensor manufacturer, formed to let the new company focus exclusively on digital health data collection and software while remaining technology-agnostic about which sensors it uses. The Cambridge, Massachusetts-based company markets the modular Verisense wearable sensor platform, originally developed by Shimmer for clinical trials and remote patient research, alongside a Digital Health Panel that has grown into a Digital Biobank containing data from more than 500 studies and over 1 million people. In January 2024, Verisense Health launched the Verisense Smart Watch, a participant-friendly device the company says delivers research-grade continuous sensor data at less than one-tenth the cost of comparable solutions. CEO Geoffrey Gill has positioned the company's Digital Biobank as a way for researchers to access relevant historical wearable and real-world data without needing to collect new patient data from scratch for every study.

Explore the full Wearables landscape

The companies above represent a portion of a much larger field.

Diligent's platform includes over 170 Wearables Vendors, with Vendor qualification data available on demand. Talk to our team about accessing qualification data for this category.

This article is intended as an informational overview of vendors operating in this space. Inclusion on this list does not constitute an endorsement, recommendation, or qualification by Diligent.