LAUSANNE, Switzerland, Dec. 18, 2024 — SmartCardia completed the acquisition of Cardiomedix, Inc., a United States Independent Diagnostic Testing Facility (IDTF). The transaction was finalized alongside FDA clearance of SmartCardia’s 7-Lead ECG Patch and cloud platform for Mobile Cardiac Telemetry (MCT) — a regulatory milestone that authorized live-streamed outpatient cardiac telemetry for the device. Together, the two events positioned SmartCardia to deliver device, software, and accredited US diagnostic services as a single integrated provider. Cardiomedix has now fully transitioned to the SmartCardia brand.

About the transaction

The acquisition closes the loop on SmartCardia’s US offering and gives the company control over the full cardiac-monitoring ecosystem. By combining its FDA-cleared 7-Lead ECG Patch and AI-driven cloud platform with an accredited US IDTF, SmartCardia now delivers each step of the remote cardiac monitoring pathway — wearable device, automated analysis, clinician-facing reporting, and US diagnostic services — under one provider. The vertically integrated model is designed to improve quality, regulatory compliance, and turnaround time for referring physicians and health systems.

SmartCardia in the United States

SmartCardia is a medical-technology company headquartered in Lausanne, Switzerland. Its flagship product is a cable-free, wearable 7-Lead ECG Patch that records seven ECG leads and multiple vital signs, streaming full-disclosure data to a clinician cloud platform for AI-assisted analysis, alerting, and reporting. Following the FDA Mobile Cardiac Telemetry clearance and the Cardiomedix acquisition, SmartCardia offers a complete end-to-end US service — spanning Mobile Cardiac Telemetry (MCT) and Holter Monitoring — backed by an accredited IDTF.

Corporate information

Following the acquisition, Cardiomedix, Inc. has been renamed SmartCardia, Inc. and now operates as the wholly-owned US subsidiary of SmartCardia SA, headquartered in Lausanne, Switzerland. US operations continue under the same CMS IDTF enrollment and Joint Commission accreditation originally held by Cardiomedix, Inc., in compliance with applicable US law, including HIPAA.

Contact

SmartCardia, Inc.
2800 S River Rd., Suite 420
Des Plaines, IL 60018
Email: contact@smartcardia.com
Phone: +1 800 522 0078