Could BioSig Play a Vital Role in the Bioelectronics Market?

BioSig Technologies is hoping to make an impact in the $4.6 billion electrophysiology (EP) market with its first product offering. The Santa Monica, CA-based company is developing the Pure EP system, a surface electrocardiogram and intracardiac multichannel device. BioSig filed said it filed for FDA clearance of the Pure EP system in late March. Once the company receives FDA clearance then it would turn its attention toward gaining regulatory clearance in Europe. “We feel like we’ve made a very robust submission to FDA,” Ken Londoner, founder and CEO of BioSig, told MD+DI. The Pure EP System is designed to cut through the background noise of the lab and its equipment during cardiac recordings, enabling physicians to target and neutralize the areas of the heart that are causing atrial fibrillation (Afib), and ventricular tachycardia (VT). More accurate targeting of the offending tissue may reduce the number of repeat catheter ablation procedures, which can last up to eight hours. Join us at the BIOMEDevice Boston Expo,  April 18–19, 2018. Use promo code "MDDI" for 20% off conference registration and free expo access.   “The Pure EP system is not a recorder and it is not a mapping system,” Londoner said. “It basically improves the signal fidelity of the surface electrocardiograms and the intracardiac signals to enable ablation procedures. It gives physicians that are doing the ablation procedures information based off those software signals.” Other compani...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Digital Health Source Type: news