www.fdanews.com/articles/187728-medicalgorithmics-mobile-cardiac-rehabilitation-system-cleared
MedicalGorithmics’ Mobile Cardiac Rehabilitation System Cleared
July 24, 2018
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.