BioSig Technologies Inc. filed a 510(k) application with the U.S. Food and Drug Administration for its PURE EP System.
The Los Angeles-based medical device company is seeking approval for the surface electrocardiogram and intracardiac multichannel recording system, which aims to produce high-fidelity heart recordings during electrophysiology studies and catheter ablation procedures.
Catheter ablation is a procedure to treat atrial fibrillation, the most common form of quivering or irregular heartbeat known as arrhythmia. Atrial fibrillation affects 6.1 million people in the U.S., increasing their risk of stroke by 4 to 5 times.
BioSig Technologies said it has conducted 11 pre-clinical studies and one clinical trial between 2015 and 2018.