Medi-Lynx’s PocketECG Cardiac Rehab System Cleared

FDA has cleared a Medi-Lynx Cardiac Monitoring 510(k) for the PocketECG Cardiac Rehabilitation System, a mobile cardiac rehabilitation designed to provide ECG monitoring and automated arrhythmia detection during rehabilitation training. The smartphone-sized device is intended to monitor a patient’s heart rhythm and heart rate during rehabilitation exercises to safely guide the intensity and duration of workouts in real-time. It transmits the full disclosure ECG signal classifying every heartbeat to automatically detect abnormalities and arrhythmia, according to the company. Additionally, a built-in accelerometer allows clinicians to analyze the impact of physical activity on heart rate. All data are streamed to a secure online clinician portal and to a cardiac monitoring center for constant monitoring, evaluation, and urgent notifications, it says.