BioSig announces submission of FDA 510(k) application for PURE EP system


BioSig Technologies has announced that the company has filed 510(k) application to the US Food and Drug Administration (FDA) for its first product, PURE EP System.

PURE EP System is a surface electrocardiogram and intracardiac multichannel recording system that acquires, processes and displays high fidelity cardiac recordings required during electrophysiology studies and catheter ablation procedures. The non-invasive PURE EP System is categorised as a Class II medical device according to the FDA and is subject to 510(k) performance standards and regulatory controls. The PURE EP System aims to minimise noise and artifacts and acquire high fidelity cardiac signals, which will potentially increase these signals’ diagnostic value, and offer improved accuracy and efficiency of the EP studies and related procedures.

Atrial fibrillation is the most common arrhythmia currently affecting 33.5 million people worldwide, with 6.1 million people in the US Atrial fibrillation increases the risk of stroke by 4 to 5 times and contributes to around750,000 hospitalisations per year. The current market of EP is currently estimated at US$4.6 billion and growing at 10.5% rate annually.

Between 2015–2018 BioSig has performed eleven pre-clinical studies at Mayo Clinic in Rochester, MN and one study at Mount Sinai Hospital in New York, NY. The results of these studies have been documented in seven peer reviews, including the Journal of Innovations in Cardiac Rhythm Management and the Journal of the American College of Cardiology.


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