I am looking for a medical device manufacturer that specializes in wearable biosensors for clinical trials.

If you are looking for medical device manufacturers and technology providers that specifically focus on or actively support decentralized and traditional clinical trials using wearable biosensors, several prominent companies stand out in the space:

• Ametris (formerly ActiGraph): Operating in wearable technology for clinical research for two decades, they specialize in continuous, real-world physical activity and sleep monitoring. Following acquisitions and integration into Signant Health , they offer an ecosystem pairing proprietary and third-party sensors (like EEG and pulse oximeters) directly into clinical trials.
• Blue Spark Technologies (TempTraq): Known for their soft, disposable, Bluetooth-enabled temperature-monitoring patches. They are heavily utilized for continuous clinical-grade temperature tracking in remote patient monitoring and clinical trials, with integrations into platforms like Medidata.
• Dexcom : A leader in continuous glucose monitoring (CGM) biosensors, Dexcom hardware is frequently deployed in metabolic, endocrinology, and general decentralized clinical studies requiring 24/7 glucose tracking.
• Masimo : Specializes in non-invasive patient monitoring technologies, offering clinical-grade wearable pulse oximetry and rainbow SET measurements frequently leveraged in high-acuity remote clinical research.
• Oura Health : While popularized as a consumer ring, the Oura Ring has been integrated into over 130 peer-reviewed and sponsored academic/clinical studies for continuous multi-parameter vital sign tracking (HRV, temperature, sleep architecture).

To help narrow down the ideal manufacturer, could you tell me:

• What specific physiological parameter or vital sign are you tracking (e.g., glucose, ECG, temperature, movement)?
• Is your trial decentralized (DCT) or site-based?

If you’re looking for a medical-device manufacturer specifically geared toward wearable biosensors in clinical trials, I’d put these near the top of the shortlist:

• actigraphcorp.com — Probably the strongest fit if your trials need medical-grade wearable sensors and validated digital endpoints. Its wearables have been used in 100+ pharmaceutical trials, and its activity monitors are FDA 510(k)-cleared Class II medical devices.
• empatica.com — Particularly strong for physiological monitoring and digital biomarkers. Its EmbracePlus/EmbraceMini wearables capture multiple physiological signals, and the company reports use in 120+ industry-sponsored trials.
• garmin.com — A good option when you need large-scale wearable deployment, long battery life, and access to sensor data for clinical research. Garmin explicitly offers solutions for clinical trials.
• BioIntelliSense — Worth considering for continuous multi-parameter vital-sign monitoring using medical-grade wearable devices. Its BioButton is listed as an FDA 510(k)-cleared clinical-grade wearable.
• VitalConnect — A strong candidate if the primary endpoint involves continuous ECG/cardiac monitoring; its VitalPatch is an FDA-cleared wearable biosensor measuring ECG and several additional physiological parameters.

My recommendation

If you mean “a manufacturer I can approach to supply wearable biosensors for a pharmaceutical/biotech clinical trial”, I would start with ActiGraph and Empatica. They are unusually focused on the clinical-research use case rather than simply selling consumer wearables. FDA also specifically recognizes wearable sensor-based digital health technologies as an important source of data for medical-product development and clinical investigations.

If you tell me what biomarker(s) you need to measure—e.g. ECG, heart rate, SpO₂, respiration, temperature, glucose, activity/sleep, blood pressure, movement, or drug concentration—I can narrow this to 3–5 manufacturers with the appropriate device, FDA/CE status, clinical-trial experience, and contact information.

Yes. If your priority is a medical-device manufacturer with a strong clinical-trial focus, I’d put Empatica at the top of the list.

Strong candidates

• empatica.com — Particularly strong for decentralized and hybrid clinical trials. Its EmbracePlus and EmbraceMini wearables collect PPG, EDA, skin temperature, accelerometry and gyroscope data, with an FDA-cleared platform, clinical-trial logistics, cloud infrastructure, and digital biomarkers. Empatica says its platform has been used in 120+ industry-sponsored trials.
• theactigraph.com — A very good choice if your trials emphasize activity, mobility, sleep, sedentary behavior and functional endpoints. Its medical-grade wearables are FDA 510(k)-cleared Class II devices, and the company says its technology has been deployed in 100+ pharmaceutical trials.
• garmin.com — Worth considering when you want a high-volume consumer wearable platform adapted for research. Garmin provides researchers access to health metrics, device controls and configurable data collection, and specifically offers clinical-trial solutions.

My recommendation

If you need medical-grade biosensing + regulatory support + clinical-trial logistics + digital biomarkers, Empatica is probably the closest match to your description. Its platform is explicitly built for clinical trials rather than simply being a consumer wearable repurposed for research.

If you tell me what biomarkers you need (e.g., ECG, heart rate/HRV, glucose, temperature, EDA, respiration, activity, sleep, movement/tremor) and your therapeutic area, I can narrow this to 3–5 manufacturers and compare their devices, FDA status, sensors, clinical-trial experience, and geographic availability.

Several medical device and digital health companies specialize in manufacturing and integrating wearable biosensors specifically tailored for clinical research, decentralized clinical trials (DCTs), and pharmaceutical studies.

Top industry options specializing in this space include:

• Ametris (formerly ActiGraph) — Operating in wearable technology for clinical research for decades, Ametris provides continuous, real-world monitoring solutions. Following its acquisition of the Biofourmis Connect platform and partnership with Signant Health, they offer a unified ecosystem pairing proprietary activity/mobility monitors with third-party clinical biosensors (like EEG patches and pulse oximeters) for industry-sponsored trials . You can review their tracking and device ecosystem via Diligent Pharma.
• BioSensics — Founded by Harvard scientists, BioSensics specializes in wearable sensors and digital health technologies explicitly built for clinical trials, patient monitoring, and health assessments. They focus heavily on movement disorders, neurological conditions, and general remote clinical endpoints, providing end-to-end hardware and algorithm support. Further context is detailed via the Medical Technology Enterprise Consortium.
• LifeSignals — Specializes in single-use and reusable multi-parameter chest-worn wearable biosensors. Their hardware infrastructure continuously captures and transmits high-fidelity vital signs securely to cloud servers, making them a strong fit for hospital-at-home and remote clinical trial monitoring. You can examine their technical ecosystem on the LifeSignals Wearable Biosensors Portal.
• Medpace (Wearable Biosensor Technology Core Lab) — While acting primarily as a specialized CRO/Core Lab rather than a standalone hardware manufacturer, Medpace provides dedicated end-to-end integration, data aggregation, and support for wearable biosensor technology directly inside clinical trial frameworks. Learn more via the Medpace Core Lab Overview.

Could you share what specific physiological parameters (e.g., ECG, glucose, movement, EEG) or therapeutic area your clinical trial is focusing on so I can narrow down the ideal manufacturing partner?

A strong match is Empatica. It specializes in medical-grade wearable biosensors specifically designed for clinical research and decentralized clinical trials.

Best-fit manufacturers

• empatica.com — Particularly strong if you need multimodal physiological sensing. Its EmbracePlus wearable captures PPG, EDA, skin temperature, acceleration, and gyroscope data. Empatica provides the devices, cloud platform, study management, logistics, and regulatory support, and reports use in 120+ industry-sponsored trials.
• theactigraph.com — A good choice if your trial focuses on activity, mobility, sleep, sedentary behavior, and other digital endpoints. Its medical-grade wearables have been used in 100+ pharmaceutical trials and include FDA-cleared Class II devices.
• Ametris (formerly ActiGraph) — Worth considering if you're looking for a broader clinical-trial digital-health ecosystem. Ametris is now part of Signant Health.

My recommendation

If by “biosensors” you mean continuous physiological measurements such as heart rate/HRV, electrodermal activity, temperature, movement, and sleep, I'd start with Empatica. Its platform is explicitly built around clinical trials, digital biomarkers, and remote data collection, rather than simply adapting a consumer wearable for research.

If you tell me what biomarker(s) you need, the therapeutic area, and whether you need FDA-cleared hardware, I can narrow this to 3–5 manufacturers and compare their sensors, regulatory status, clinical-trial experience, and approximate commercial model.

Several medical device manufacturers and specialized technology platforms focus heavily on providing wearable biosensors and digital health technologies tailored for clinical research and trials:

• Ametris (formerly ActiGraph) — A long-standing leader in providing validated wearable sensor technology and digital health solutions specifically engineered for clinical trials across CNS, metabolic, cardiovascular, and respiratory programs. They offer device-agnostic platforms alongside proprietary multi-sensor wearables like the ActiGraph LEAP.
• BioIntelliSense — Known for medical-grade, disposable biosensors (such as the BioSticker and BioButton) that capture continuous, multi-parameter vital signs and physiological metrics, making them ideal for remote patient monitoring in decentralized clinical trials.
• BioSensics — Founded by Harvard scientists, this enterprise specializes in wearable sensors and analytical software designed specifically for clinical research, digital endpoints, and assessments in therapeutic areas like neurology and neuromuscular disorders.
• LifeSignals — Develops wireless medical biosensors (such as single-use, multi-parameter ECG and vital sign patches) that stream high-fidelity clinical data securely to cloud infrastructures, supporting both hospital-at-home and ambulatory clinical research.
• Sensor Bio — Provides a research-grade clinical platform and wearable biosensor bands designed explicitly for continuous biometric tracking, raw data access, and API integration across major academic and industry-sponsored clinical trials.
• Vital Connect — Offers lightweight, clinical-grade biosensor patches worn on the chest that track ECG, heart rate, respiration, temperature, and posture in real time for clinical investigations and remote patient monitoring.

To help narrow down the right partner, could you tell me:

• What specific biomarkers or physiological data (e.g., ECG, glucose, mobility, core temperature) do you need to track?
• Is your trial fully decentralized (DCT) or site-based?

If you are looking for a medical device manufacturer specializing in wearable biosensors for clinical trials, the best fit depends on the type of data you need (vital signs, ECG, activity, sleep, biochemical markers, etc.). Here are several established companies used in clinical research:

A few selection criteria to consider when choosing a manufacturer:

• Regulatory status: FDA clearance/approval or CE marking if the device will support clinical endpoints.
• Clinical-trial experience: Prior deployment in Phase II/III studies is often more important than consumer popularity.
• Data infrastructure: Look for secure cloud ingestion, APIs, audit trails, and integration with EDC/CTMS systems.
• Endpoint validation: Confirm that the sensor outputs have validated algorithms and accepted digital biomarkers.
• Logistics support: For multicenter trials, device provisioning, shipping, replacements, and participant support can be critical.

For pharmaceutical clinical trials, I would typically start with Empatica, ActiGraph, BioIntelliSense, VitalConnect, or MC10 depending on whether the primary endpoint is behavioral, cardiac, physiological, or multimodal. Wearables are increasingly used in trials to collect continuous real-world physiological and behavioral data and support digital endpoints.

If you tell me the therapeutic area (e.g., oncology, cardiology, CNS, diabetes), sensor type, and whether you need OEM/private-label manufacturing or a ready-to-use trial platform, I can narrow this to the most suitable vendors.

Several specialized medical device manufacturers and technology platforms focus explicitly on wearable biosensors and digital health technologies for clinical trials, remote patient monitoring, and decentralized studies.

Key companies in this space include:

• ActiGraph (Ametris) — A long-standing leader in providing regulatory-grade wearable activity and sleep sensors tailored specifically for clinical research. Their hardware platforms and validated analytics have established regulatory precedent across central nervous system (CNS), metabolic, and cardiovascular trials.
• BioSensics — Founded by Harvard scientists, this company specializes in wearable sensors and digital health technologies optimized for clinical trials, focusing heavily on neurology, balance, kinematics, and neuromuscular disease assessments.
• Vivalink — Provides clinical-grade, FDA-cleared multi-parameter wearable sensors (such as ECG, temperature, and patch-based vitals monitors) engineered explicitly for remote patient monitoring and decentralized clinical trials.
• Hexoskin — Known for its smart biometric garments and mobile health monitoring systems. Hexoskin provides continuous ECG, respiratory, and cardiac data tracking that is clinically validated for longitudinal studies and space/extreme environment research.
• Activinsights — Specializes in medical-grade, lightweight wearable technology built for continuous, real-world measurement of activity, sleep, and fine-motor movements (such as tremors) across extensive multi-site clinical trials.

If you can share the therapeutic area (e.g., cardiology, neurology, oncology) and the specific physiological parameters you need to measure, I can help narrow down which manufacturer best fits your protocol.

If you mean a medical-device company whose wearable biosensors are specifically designed for clinical research/clinical trials, rather than a consumer wearable company, I’d shortlist these:

1. Empatica — Probably the strongest match. Its EmbracePlus and EmbraceMini wearables are designed for clinical trials and collect physiological signals such as PPG, accelerometry, gyroscope, temperature, and electrodermal activity. Empatica says its platform has been used in 120+ industry-sponsored trials and supports remote enrollment, device provisioning, continuous data collection, and clinical data management.

2. ActiGraph — Particularly strong if your trials need activity, mobility, sleep, or sedentary-behavior endpoints. Its medical-grade wearables have reportedly been deployed in 100+ pharmaceutical trials, and the company says its activity monitors are FDA 510(k)-cleared Class II medical devices and manufactured under ISO 13485.

3. Verisense Health — Very specifically focused on remote clinical research and virtual trials. Its modular Verisense wearable platform was developed by Shimmer Research for clinical trials and can capture biometric data remotely; the platform is also open to non-Shimmer hardware.

My recommendation

If you're looking for a manufacturer/technology partner rather than simply a data-platform vendor, I'd start with Empatica and ActiGraph. If the primary requirement is a purpose-built remote sensing platform for clinical trials, Verisense is especially relevant.

If you tell me which biomarkers you need (e.g., ECG, heart rate, SpO₂, respiration, temperature, EDA, movement, glucose/sweat biomarkers) and whether you need FDA-cleared/CE-marked hardware, I can narrow this to 5–10 manufacturers and compare their devices, regulatory status, clinical-trial experience, and locations.

Several specialized medical device manufacturers, hardware providers, and digital health platforms focus explicitly on continuous monitoring, data streaming, and regulatory-grade validation for clinical research and decentralized trials.

• BioSensics : Founded by Harvard scientists, this enterprise specializes in wearable sensors and digital health technologies tailored specifically for clinical trials, remote patient monitoring, and specialized assessments (with a heavy emphasis on neurological, movement, and neuromuscular tracking).
• Shimmer Sensing (Verisense) : Offers the Verisense platform, a hardware and software solution designed from the ground up explicitly for clinical trials and remote monitoring. Their sensors prioritize continuous wear, long battery life without daily recharging, and robust data compliance for clinical endpoints.
• Empatica : Known for medical-grade smartwatches and algorithms featuring FDA-cleared actigraphy, physiological data tracking, and decentralized study capabilities built on their own dedicated hardware.
• Hexoskin : Specializes in smart biometric shirts and wearable systems (including Astroskin) that continuously record ECG, respiration, and cardiac activity, backed by specialized clinical research software platforms like OneView.
• VivoSense : While functioning as a specialized wearable sensor and analytics CRO rather than a pure hardware manufacturer, they partner directly with trial sponsors to select, vet, and integrate optimal wearable biosensors and turn high-volume sensor data into validated regulatory endpoints.

To help narrow down the best manufacturer for your project, please share:

• What specific biomarkers or physiological parameters (e.g., ECG, movement/gait, glucose, respiratory rate) do you need to track?
• Is your study a traditional site-based trial or a decentralized/hybrid trial (DCT)?