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.Continue reading