Technology | Cardiac Rehabilitation | July 24, 2018

FDA Clears PocketECG CRS Mobile Cardiac Rehabilitation System

New device offers data critical to effective cardiac rehab training

Now cleared by the FDA, PocketECG CRS is a new mobile cardiac rehabilitation system designed to provide high-quality ECG monitoring and automated arrhythmia detection during rehabilitation training. The device monitors a patient's heart rhythm and heart rate to safely guide the intensity and duration of rehabilitation exercises in real-time.

Now cleared by the FDA, PocketECG CRS is a new mobile cardiac rehabilitation system designed to provide high-quality ECG monitoring and automated arrhythmia detection during rehabilitation training. The device monitors a patient's heart rhythm and heart rate to safely guide the intensity and duration of rehabilitation exercises in real-time.

July 23, 2018 — The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the PocketECG Cardiac Rehabilitation System (CRS). The new mobile cardiac rehabilitation system is designed to provide high-quality ECG monitoring and automated arrhythmia detection during rehabilitation training. The clearance was announced by the maker MedicAlgorithmics and U.S. subsidiary Medi-Lynx Cardiac Monitoring LLC.

The device is currently approved and marketed in the European Union and patented in the U.S. (U.S. Patent No. 9,846,764) for use in low and high-risk cardiac patients.

"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," said Marek Dziubinski, Ph.D., CEO of MedicAlgorithmics. "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."

PocketECG CRS is a smartphone-sized device that monitors a patient's heart rhythm and heart rate during rehabilitation exercises to safely guide the intensity and duration of workouts in real-time. The system transmits the full disclosure ECG signal classifying every heartbeat to automatically detect abnormalities and arrhythmia. A built-in accelerometer allows clinicians to analyze the impact of physical activity on heart rate. All data are streamed via mobile telephony network to a secure online clinician portal and to a cardiac monitoring center for constant monitoring, evaluation, and urgent notifications.

Cardiac rehab or medically supervised exercise training is highly recommended by the American Heart Association (AHA) and shown 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. The American Association of Cardiovascular and Pulmonary Rehabilitation estimates that at least 3.8 million patients are eligible to receive cardiac rehabilitation.

This device technology is part of a larger trend in remote ECG monitoring devices. Read more on these advances.

For more information: www.medicalgorithmics.com, www.medi-lynx.com

Related Content

79-year-old Tony Marovic had a right carotid endarterectomy shortly after discovering a 95 percent blockage of his carotid artery at a health and wellness screening event

79-year-old Tony Marovic had a right carotid endarterectomy shortly after discovering a 95 percent blockage of his carotid artery at a health and wellness screening event. Image courtesy of University Hospitals.

News | Cardiac Diagnostics | October 16, 2019
Health and wellness screenings are more than just nice events for the community – they can save lives. A Mentor, Ohio,...
Pesticide Exposure May Increase Heart Disease and Stroke Risk

Image courtesy of zefe wu from Pixabay

News | Cardiac Diagnostics | October 15, 2019
On-the-job exposure to high levels of pesticides raised the risk of heart disease and stroke in a generally healthy...
World Heart Federation Launches Global Roadmap on Cardiovascular Disease Prevention Among Diabetics
News | Cardiac Diagnostics | September 04, 2019
At the European Society of Cardiology (ESC) Congress 2019 together with the World Congress of Cardiology, the World...
Insomnia Tied to Higher Risk of Heart Disease and Stroke

Image courtesy of the American Heart Association

News | Cardiac Diagnostics | August 19, 2019
People suffering from insomnia may have an increased risk of coronary artery disease, heart failure and stroke,...
Evolutionary Gene Loss May Help Explain Human Predisposition to Heart Attacks
News | Cardiac Diagnostics | July 29, 2019
The loss of a single gene two to three million years ago in our ancestors may have resulted in a heightened risk of...
U.S. Soldiers Have Worse Heart Health Than Civilians
News | Cardiac Diagnostics | June 06, 2019
Active duty Army personnel have worse cardiovascular health compared to people of similar ages in the civilian...
Late Dinner and No Breakfast Worsens Outcomes After Heart Attack
News | Cardiac Diagnostics | May 23, 2019
People who skip breakfast and eat dinner near bedtime have worse outcomes after a heart attack, according to research...
HRS Releases New Expert Consensus Statement on Arrhythmogenic Cardiomyopathy
News | Cardiac Diagnostics | May 14, 2019
The Heart Rhythm Society (HRS) released a first-of-its-kind consensus statement with guidance on the evaluation and...
New Best Practices Help Manage Heart Attack Patients Without Significant Signs
News | Cardiac Diagnostics | April 15, 2019
For the first time in the United States, doctors with the American Heart Association (AHA) have outlined best practices...
Overlay Init