Smartphone-Sized Cardiac Monitor Receives FDA 510(k) Clearance

MEDICALgorithmics and its US subsidiary Medi-Lynx Cardiac Monitoring LLC, have announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the PocketECG Cardiac Rehabilitation System (CRS). The mobile cardiac rehabilitation system is designed to provide ECG monitoring and automatically detects arrhythmia during rehabilitation exercises.

"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," said Marek Dziubinski, PhD, CEO of MEDICALgorithmics, in a statement.

The PocketECG Cardiac Rehabilitation System transmits a full ECG signal of each heartbeat during rehabilitation to monitor heart rhythm and heart rate in real-time. It automatically detects abnormalities and arrhythmia. Data are transmitted via mobile network to a secure clinician portal and to a cardiac monitoring center, providing constant monitoring, evaluation, and urgent notifications.

The device additionally incorporates an accelerometer that allows clinicians to observe the impact of physical activity on heart rate.

The Pocket ECG CRS is smartphone-sized—small enough to be unobtrusive during cardiac rehabilitation or medically supervised exercise following acute myocardial infarction, chronic stable angina, coronary artery bypass grafting, percutaneous coronary intervention, cardiac valve surgery, stable, chronic heart failure, or cardiac transplantation.

"We are thrilled to now introduce PocketECG CRS to patients and clinicians in the US, providing a valuable monitoring tool with the potential to improve the effectiveness of cardiac rehabilitation training," said Dziubinski.

The PocketECG is currently approved for use in low- and high-risk patients in the European Union and in the US.