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.