MediPlex Receives FDA 510(k) Clearance for AI-Assisted Cardiac Diagnostic Device

MediPlex Healthcare today announced that its CardioScan AI system has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), paving the way for commercial launch across U.S. cardiac care facilities.

CardioScan AI uses a proprietary deep-learning model trained on over 4.2 million ECG recordings to detect early indicators of atrial fibrillation, heart block, and other arrhythmias with a reported sensitivity of 97.3% — outperforming standard cardiologist interpretation in blinded clinical studies.

“Cardiovascular disease is the leading cause of death globally, and late detection is the primary driver of poor outcomes,” said Chief Medical Officer Dr. Anya Kowalski. “CardioScan AI gives clinicians a second opinion in seconds.”

The device integrates with all major electronic health record (EHR) systems and can be deployed as a bedside unit or integrated into existing ECG hardware.

Commercial rollout in the United States begins in Q4 2025, with European CE Mark submission expected in Q1 2026.

About MediPlex Healthcare MediPlex Healthcare develops AI-assisted diagnostics and clinical decision-support tools for cardiology, oncology, and neurology. The company is headquartered in Zurich, Switzerland.

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