The FDA granted 510(k) clearance for MedicalGorithmics and U.S. subsidiary Medi-Lynx Cardiac Monitoring’s PocketECG cardiac rehabilitation system.

The device is used during rehabilitation training for automated arrhythmia detection and electrocardiography (ECG) monitoring.

The device, about the size of a smartphone, monitors the heart rate and heart rhythm of patients during rehabilitation exercises to automatically detect abnormalities and arrhythmias, helping them stay aware of workout safety and intensity.