16 Wearable Device Companies for Clinical Trials in 2026

Wearable devices have become a standard tool for collecting continuous, objective physiological data directly from clinical trial participants, reducing dependence on intermittent site visits and supporting decentralized and hybrid trial designs. A clinical trial wearables provider typically supplies not just the device itself but the data infrastructure, regulatory clearances, and analytics needed to turn raw sensor signals into validated digital measures and endpoints that Sponsors can use across therapeutic areas from cardiology to neurology.

The companies on this list, presented in no particular order, offer a range of wearable device services for clinical trials, spanning wrist-worn actigraphy trackers, adhesive ECG and temperature patches, continuous glucose monitors, pulse oximetry sensors, respiratory chest straps, and full smart garments. Together, these providers and vendors support digital biomarker development, remote patient monitoring, and decentralized data collection, giving Vendor qualification teams and Sponsors a broad set of options for building wearable-enabled endpoints into a study protocol.

Activinsights

Activinsights has generated data from more than 500,000 patients and participants across 40 countries using its wearable sensor technology, according to the company. Founded in 2008 and based in Kimbolton, England, the provider designs its GENEActiv and Activinsights Band wearables specifically for long-term, low-burden clinical monitoring, with battery life stretching up to a year without charging. The devices collect raw, unfiltered accelerometer data on activity, sleep, and lifestyle, which the company states supports the development of digital clinical measures and endpoints. Activinsights reports involvement in more than 200 clinical trials spanning over 20 therapeutic areas, including cardiology, dermatology, and neurology.

AliveCor

AliveCor's KardiaMobile line offers what the company describes as the most clinically validated personal ECG technology on the market, with its six-lead KardiaMobile 6L device providing FDA-cleared detection of atrial fibrillation, bradycardia, and tachycardia. The devices pair with a smartphone app to deliver a single- or multi-lead ECG reading in as little as 30 seconds, without requiring a clinician visit. AliveCor, headquartered in Mountain View, California, has also introduced a credit-card-sized ECG device and a companion cardiologist-review service. Founded in 2010, the provider continues to expand its FDA clearances for arrhythmia detection.

Ametris (formerly ActiGraph)

Ametris has operated in wearable technology for clinical research since 2004, when it launched as ActiGraph and helped establish actigraphy as a standard tool for continuous, real-world monitoring in academic and pharmaceutical studies. The Pensacola, Florida-based provider rebranded to Ametris in 2025 following its acquisition of the Biofourmis Connect digital trial platform, expanding its offering into a unified ecosystem that pairs proprietary wearable devices with third-party sensors such as EEG patches and pulse oximeters. In 2026, Ametris joined Signant Health, combining its wearable-derived digital measures with Signant's eCOA solutions. The company states it has supported nearly 300 industry-sponsored trials.

BioIntelliSense

BioIntelliSense's FDA-cleared BioButton is a coin-sized, chest-worn wearable that continuously records heart rate, respiratory rate, skin temperature, and activity levels, collecting up to 1,440 measurements per patient per day. Golden, Colorado-based BioIntelliSense, founded in 2018, pairs the device with its BioCloud data service and BioDashboard clinical intelligence system to support both in-hospital and at-home continuous monitoring. The company reports that its device has been used to gather more than 651,000 patient-hours of vital sign data in observational studies. BioIntelliSense positions the platform as a data-as-a-service model for virtual care and remote patient monitoring.

Blue Spark Technologies

Blue Spark Technologies' TempTraq is a soft, disposable, Bluetooth-enabled patch that continuously monitors body temperature for up to 72 hours and sends alerts to a connected mobile device. The Westlake, Ohio-based vendor, founded in 2002, holds a U.S. patent on the underlying body-temperature-logging technology and has secured both FDA clearance and CE Mark approval for the wearable. TempTraq has been evaluated in studies at institutions including the Cleveland Clinic and Cincinnati Children's Hospital, and the company states its Sensor Cloud integration supports clinical trial data collection through partners such as Medidata. Blue Spark describes itself as a specialist in thin, flexible printed-electronics technology for wearables and medical devices.

ChroniSense Medical

ChroniSense Medical's Polso is a wrist-worn wearable that the company positions for use in both remote patient monitoring and decentralized clinical trials, measuring blood oxygen saturation, pulse rate, and respiration rate. Based in Yokneam Illit, Israel and founded in 2015, the vendor received its first FDA 510(k) clearance for the device in 2022 following clinical validation studies conducted in hospital settings. ChroniSense states that Polso combines a medical-grade wrist monitor with a companion mobile app and a cloud-based platform for clinician review. The company continues to develop the platform in collaboration with hospital and research partners.

Dexcom

Dexcom's continuous glucose monitoring systems, including the Dexcom G7, are wearable sensors that attach to the skin and transmit real-time glucose readings every five minutes without requiring fingersticks. Founded in 1999 and headquartered in San Diego, California, the company has become a widely used CGM provider in diabetes research, with its sensors appearing across clinical trials studying glycemic control in surgical, pediatric, and pregnant populations. Dexcom sensors are typically worn for 10 to 15 days per session and are frequently used as the study device in trials sponsored directly by Dexcom or by independent academic centers. The company's G7 platform received FDA clearance for extended 15-day wear.

Empatica

Empatica develops AI-enabled medical-grade wearables, including its EmbracePlus smartwatch and the compact EmbraceMini, which the provider states can passively monitor more than 200 digital measures across physical activity, sleep, gait, and light exposure. Boston-based Empatica, founded in 2011, offers a modular design that lets its devices be worn on the wrist, leg, waist, or ankle, and the U.S. Department of Defense selected EmbracePlus to monitor participants in a Phase 2 PTSD treatment study. The company's Health Monitoring Platform centralizes wearable data, digital biomarkers, and compliance metrics for sponsors, CROs, and site teams. Empatica reports offering more than 300 digital measures through its platform and partner algorithms.

Hexoskin

Hexoskin's textile-embedded smart garments continuously monitor cardiac, respiratory, and activity data, and the Montreal-based company's technology has flown aboard the International Space Station as part of the Canadian Space Agency's Astroskin Bio-Monitor program since 2019. Founded in 2006, Hexoskin states its garments have been used in more than 300 scientific publications and by customers including NASA, the U.S. Department of Defense, and Yale Health. The vendor offers turnkey services to support sensor and software deployment directly within clinical trials, alongside its Hexoskin OneView clinical research software. Hexoskin's garments are also used in defense and first-responder research beyond clinical and aerospace settings.

iRhythm Technologies

iRhythm Technologies combines its Zio wearable biosensor patches with cloud-based analytics and a deep-learning algorithm to detect and classify cardiac arrhythmias. The company's Zio XT patch adheres to the chest for continuous ECG recording for up to 14 days, and iRhythm states the Zio Service has been used with more than 400,000 patients across nearly 1,000 U.S. institutions. San Francisco-based iRhythm launched its long-term continuous monitoring system commercially in Japan in 2025 through an exclusive distribution partner. The provider's algorithm has FDA 510(k) clearance, CE Mark, UKCA mark, and PMDA approval.

Masimo

Masimo's SET pulse oximetry technology underpins a wide range of noninvasive wearable sensors used to continuously monitor oxygen saturation, pulse rate, and other physiologic parameters, and the company states its sensors serve as the primary pulse oximetry technology in all top 10 U.S. hospitals. Irvine, California-based Masimo's Radius PPG sensor is a tetherless, wearable pulse oximeter designed to let patients move freely while remaining continuously monitored. The vendor's rainbow SET platform extends monitoring to additional parameters, including total hemoglobin and carboxyhemoglobin, through its Root patient monitoring and connectivity system. Masimo reports its SET technology helps clinicians monitor more than 200 million patients annually worldwide.

Caretaker Medical

Caretaker Medical's VitalStream is billed by the company as the world's only FDA-cleared wireless, wearable monitor for continuous cardiac output and blood pressure, using a single finger sensor in place of an arterial catheter. The Charlottesville, Virginia-based vendor, founded in 2014, built the device on its proprietary Pulse Decomposition Analysis technology, which the company states performs roughly 1,200 data-point comparisons per second to derive a beat-by-beat hemodynamic profile. Caretaker Medical has secured multiple FDA 510(k) clearances expanding VitalStream's parameters to include cardiac output, stroke volume, and heart rate variability, and the wrist-worn unit can undock from bedside equipment so monitoring continues as a patient moves through the hospital. The company positions VitalStream as a noninvasive alternative to arterial lines across critical care, surgical, and hospital-at-home settings.

Sibel Health

Sibel Health, a spin-out of Northwestern University, develops soft, skin-conformable wearable sensors under its ANNE brand, which the provider states have received multiple FDA 510(k) clearances for continuous monitoring of heart rate, respiratory rate, SpO2, blood pressure, and temperature. Chicago-based Sibel Health, founded in 2018, released its Discovery platform for clinical trial use in 2023 alongside a technology partnership with Medidata. The company's ANNE Maternal system, developed with support from the Gates Foundation, extends wireless maternal and fetal vital-sign monitoring to low-resource settings across India, Pakistan, Nigeria, and Rwanda. Sibel Health markets its wearables as zero-cable devices that let patients remain untethered while continuously monitored.

Spire Health

Spire Health's Health Tag is a small, clip-on wearable that the company states enables continuous respiratory sensing alongside activity and sleep monitoring, positioned for long-term clinical studies conducted outside traditional care settings. San Francisco-based Spire Health, founded in 2013, has supported observational studies examining predictors of COPD exacerbations and has been used in wearable respiratory monitoring research among survivors of childhood cancer. The vendor describes its sensor as measuring the full motion of every breath, generating a waveform it compares to an ECG for breathing. Spire Health's Research Platform provides sponsors with both processed and raw sensor data for use in remote, longitudinal trials.

Verisense Health

Verisense Health launched in 2023 as a spin-off of Shimmer Research, a wearable sensor manufacturer, and has built what it calls a digital biobank of longitudinal, real-world sensor data intended to let researchers conduct digital health studies without collecting new patient data. The Cambridge, Massachusetts-based provider's Verisense wearable can continuously measure activity and sleep for up to six months without recharging, according to the company. Verisense Health's Digital Health Panel recruits both clinical study participants and healthy volunteers under an IRB-approved longitudinal protocol that combines wearable sensor data with patient-reported outcomes and tokenized real-world data. The company also markets a research-grade smart watch built on the same sensing platform.

Vitls

Vitls' Tégo wearable is a thin, flexible, waterproof, disposable sensor that the company states continuously monitors body temperature, pulse, heart rate variability, respiration rate, oxygen saturation, sleep, and movement for up to six days per charge. Houston-based Vitls, founded in 2016, received FDA 510(k) clearance for its full platform in 2020, which pairs the Tégo device with the Vitls Cloud and a companion app for real-time review by care teams. The vendor positions the wearable for both hospital and home monitoring, aiming to support earlier intervention when a patient's vital signs begin to shift. Vitls states that continuous, remote monitoring can help identify patient deterioration substantially earlier than intermittent manual checks.

Explore the full Wearables landscape

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

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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.