Silver Spring, Maryland, USA: Plano, Texas-based MediLynx, the US subsidiary of Poland’s Medicalgorithmics, has received FDA 510(k) clearance for its PocketECG CRS Mobile Cardiac Rehabilitation System.
The product is a new application of the company’s existing (and previously FDA-cleared) PocketECG technology, which can monitor cardiac patients for arrhythmias remotely for up to 30 days. The device captures the full ECG signal and streams it via a cellular network to an online monitoring platform and physician portal. The device also includes a built-in accelerometer and a touch screen that allows patients to report symptoms — allowing caregivers to see how ECG, activity, and symptom data interact over time.
“Medicalgorithmics has applied the PocketECG technology over to the cardiac rehabilitation space, engineering new rehabilitation training software that would allow clinicians to monitor rehabilitation training real-time, adjust the intensity of the workout and accurately assess heart risks,” Medicalgorithmics CEO Marek Dziubinski told MobiHealthNews in an email. “This is a space that’s been getting a lot of visibility from the [American Heart Association], particularly since research demonstrates the clinical benefit of cardiac rehabilitation but many patients are either not referred or stop training before the optimal completion time.”
The CRS device is already on the market in the European Union. It employs the same technology the company currently uses to monitor diagnosed and at-risk patients and applies it to cardiac rehabilitaiton patients, who have already experienced a heart attack, heart failure, angioplasty, or heart surgery.
Cardiac rehabilitation consists of a number of elements, including nutrition counseling and stress reduction, but one of the most important to patients’ longterm health is getting enough exercise. PocketECG will allow cardiac rehabilitation supervisors to recommend a safe amount of exercise, track patients’ progress, and monitor their heart health.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Electrocardiogram (ECG or EKG)
An electrocardiogram — abbreviated as EKG or ECG — is a test that measures the electrical activity of the heartbeat. With each beat, an electrical impulse (or “wave”) travels through the heart. This wave causes the muscle to squeeze and pump blood from the heart. A normal heartbeat on ECG will show the timing of the top and lower chambers.
The right and left atria or upper chambers make the first wave called a “P wave” — following a flat line when the electrical impulse goes to the bottom chambers. The right and left bottom chambers or ventricles make the next wave called a “QRS complex.” The final wave or “T wave” represents electrical recovery or return to a resting state for the ventricles.
An ECG gives two major kinds of information. First, by measuring time intervals on the ECG, a doctor can determine how long the electrical wave takes to pass through the heart. Finding out how long a wave takes to travel from one part of the heart to the next shows if the electrical activity is normal or slow, fast or irregular. Second, by measuring the amount of electrical activity passing through the heart muscle, a cardiologist may be able to find out if parts of the heart are too large or are overworked.
There’s no pain or risk associated with having an electrocardiogram. When the ECG stickers are removed, there may be some minor discomfort. The machine only records the ECG. It doesn’t send electricity into the body.