MEDICALgorithmics, along with its US subsidiary Medi-Lynx Cardiac Monitoring, has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its PocketECG cardiac rehabilitation system (CRS).
The PocketECG mobile cardiac rehabilitation system will provide enhanced ECG monitoring and automated arrhythmia detection during rehabilitation training.
It allows remote monitoring of cardiac disorders, accurate arrhythmia diagnosis, and heart-rate monitoring.
At present, the device is approved and sold in the European Union, as well as patented in the US for use in low and high-risk cardiac patients.
PocketECG CRS is a smartphone-sized device, which monitors a patient’s heart rhythm and heart rate during rehabilitation exercises to securely guide the intensity and duration of workouts in real-time.
The system transfers the full disclosure ECG signal classifying every heartbeat to automatically detect abnormalities and arrhythmia.
All data are streamed through mobile telephony network to a secure online clinician portal and cardiac monitoring center for constant monitoring, evaluation, and urgent notifications.
According to MEDICALgorithmics, CR or medically supervised exercise training is recommended by the American Heart Association and demonstrated to improve the health and recovery of patients with acute myocardial infarction or heart attack, chronic stable angina, coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), cardiac valve surgery, stable, chronic heart failure, and cardiac transplantation.
MEDICALgorithmics CEO Marek Dziubinski said: “We are thrilled to now introduce PocketECG CRS to patients and clinicians in the U.S., providing a valuable monitoring tool with the potential to improve the effectiveness of cardiac rehabilitation training.
“PocketECG CRS was built on our PocketECG arrhythmia monitoring solution platform, and includes new software and enhancements specifically designed for use during all phases of the cardiac rehabilitation process – from early mobilization during hospitalization to post-discharge and ongoing maintenance.”
MEDICALgorithmics, which provides cardiac monitoring and diagnostic solutions, is also involved in the development of various other products such as software to optimize repetitive tasks in hospitals and algorithms for remote interpretation of multi-lead electrocardiography (ECG) signals.
In addition, the firm offers services in the field of information technology, biotechnology and scientific research.