Montreal, Canada — November 19, 2025 — Carré Technologies Inc. (dba Hexoskin), a pioneer in wearable health technologies, today announced that its Hexoskin Medical System (HMS) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for continuous long-term ECG, respiratory monitoring, and activity. The system, which includes a smart biometric shirt and a secure data management platform, has now been cleared for use in the United States to record, display, and store electrocardiogram (ECG) and respiratory signals in ambulatory patients.
The Hexoskin Medical System enables real-world cardiopulmonary monitoring—a critical unmet need in healthcare and clinical research. With FDA clearance, HMS becomes one of the first medical-grade wearable systems capable of long-term ECG and respiratory measurements outside the clinic, transforming how patients are monitored and how treatments are evaluated.
Image courtesy of Hexoskin
Enabling a New Era in Long-Term Cardiopulmonary Monitoring
Traditional adhesive-based Holter monitors and ECG patches are limited and can cause skin irritation, adding to the patients’ burden. The HMS offers comfortable, continuous data collection with smart textiles, allowing physicians to assess arrhythmias, such as atrial fibrillation, bradycardia, tachycardia, ventricular and supraventricular ectopic beats, and other transient cardiac events, as well as breathing rate patterns and activity.
“The ability to measure both cardiac and respiratory signals continuously at home provides a comprehensive picture of patient health in their daily lives,” said Pierre-Alexandre Fournier, CEO and Co-Founder of Hexoskin. “This is a game changer for remote care, decentralized clinical trials, and the development of digital biomarkers for chronic diseases.”
A Transformative Tool for Clinical Trials
Hexoskin products are already used by leading research centers and pharmaceutical companies worldwide. With FDA 510(k) clearance, this new wearable device can now be deployed in regulated U.S. clinical trials to collect real-world data with clinical-grade accuracy, accelerating the development of new treatments.
Hexoskin research tools also include a software platform designed for AI-based digital biomarker discovery, enabling new phenotyping strategies in cardiology, pulmonology, neurology, and rare disease research. The continuous data can improve endpoint sensitivity, reduce patient burden, and support remote trial models that are more inclusive and cost-effective.
Unlocking a Brighter Future for Millions of Patients and Care Providers
The global market for remote patient monitoring is projected to exceed $32 billion by 2030, driven by aging populations, rising chronic disease burden, and healthcare digitization.
Globally, cardiovascular disease (CVD) is the number one killer, claiming over 19 million lives in 2021 alone. Chronic respiratory diseases are similarly devastating; Chronic Obstructive Pulmonary Disease (COPD) alone is the fourth-leading cause of death worldwide. The sheer scale of the patient population globally includes an estimated 612 million people living with CVD, 260 million with asthma, and over 213 million with COPD.
This immense burden translates into a daily struggle for patients, a heavy emotional and financial toll on families, and an unsustainable economic strain on the healthcare system from costly, repeat hospitalizations.
With the Hexoskin Medical System now FDA-cleared, millions of patients in the U.S. will benefit from precise health monitoring with non-invasive and portable smart garments. This vast patient population includes a portion of the 127 million U.S. adults living with cardiovascular disease and the 28 million Americans with asthma, and the estimated 30 million Americans living with COPD—nearly half of whom remain undiagnosed.
“We built the Hexoskin Medical System to bring clinical-grade monitoring into the home, with comfort and usability that patients can live with during daily activities,” said Fournier. “It’s an important step toward more personalized, proactive care.”
About Hexoskin
Hexoskin is a leader in smart clothing and wearable health technologies, offering solutions for continuous monitoring of vital signs in clinical, research, and spaceflight settings. Since 2012, Hexoskin has worked with academic institutions, healthcare providers, and global partners to advance digital health and evidence-based care.
Learn more at www.hexoskin.com
Copy of the FDA Clearance Letter:
U.S. Food and Drug Administration 510(k) – Clearance Letter – Hexoskin Medical System
Further Information and Requests for Quotes & Interviews:
Pierre-Alexandre Fournier CEO & Co-Founder, Hexoskin media@hexoskin.com
Carré Technologies Inc. (Hexoskin) 5800, rue Saint-Denis, suite 601 Montreal (Quebec)
Canada, H2S 3L5 www.hexoskin.com
+1 888-887-2044