March 21, 2016 — BioSig Technologies Inc. announced it has signed an agreement to initiate development of its Pure EP high-fidelity cardiac electrophysiology (EP) signal acquisition and analysis system with Minnetronix, a medical technology development and manufacturing firm.
The Pure EP System is a surface electrocardiogram and intracardiac multichannel signal acquisition and analysis system designed to assist electrophysiologists in making clinical decisions in real time. The system acquires and displays high-fidelity cardiac signal recordings and provides clarity of data which may be used to guide the electrophysiologists in identifying ablation targets — areas of tissue to treat that otherwise create a heart rhythm disturbance (arrhythmia).
Analysts forecast the global market for EP devices will grow at a 12.1 percent compound annual growth rate, from $2.5 billion in 2012 to $5.5 billion by 2019, making it one of the fastest growing medical device segments. Just in the United States, the number of atrial fibrillation (AF) and ventricular tachycardia (VT) arrhythmia ablations is forecast to grow at 10.5 percent from 2012 to 2017.
BioSig intends to seek U.S. Food and Drug Administration (FDA) 510(k) clearance for the Pure EP System. The company has achieved proof of concept validation through University of California Los Angeles (UCLA) labs, and has performed pre-clinical studies at the Mayo Clinic in Minnesota. The company is collaborating with several of the nation's most prestigious cardiac arrhythmia centers including Texas Cardiac Arrhythmia Institute, UCLA Cardiac Arrhythmia Center and Mayo Clinic.
For more information: www.biosigtech.com