A 510(k) Application in 2017 Could Make for Expedited Commercialization
SANTA MONICA, CA / ACCESSWIRE / January 12, 2017 / Online Media Group Covers BioSig Technologies, Inc. (OTCQB: BSGM). Refined in collaboration with prestigious institutions such as the Texas Cardiac Arrhythmia Institute, Mayo Clinic, Mount Sinai and UCLA with data presented at world-renowned conferences, the PURE EP System has the potential to shorten procedure time and reduce the necessity for repeated procedures that are frequent with current devices. The PURE EP System has been featured in an article written by researchers from the prestigious Mayo Clinic and published online in The Journal of the American College of Cardiology: Clinical Electrophysiology (JACCCEP).
Many of today's EP systems have limited dynamic range, which translates into problems in needing to amplify small signals in order to see them, which ultimately distorts resolution and saturates large signals. Electrical noise is also an issue, which makes it difficult for clinicians to differentiate real physiologic signals from noise. BioSig's PURE EP System has shown effective in helping to solve these issues.
BioSig's PURE EP™ System is a surface electrocardiogram (ECG) and intracardiac multichannel recording and analysis system developed to assist electrophysiologists in making clinical decisions in real-time, albeit diagnostic or during an ablation procedure.
Because the PURE EP qualifies with the FDA as a Class II medical device, extensive clinical trials are not required. BioSig plans to file for a 510(k) marketing clearance which creates a relatively short path to commercialization, and only requires BioSig to show the device to be safe and substantially equivalent to another product on the market. BioSig intends to file its 510(k) application in the first half of 2017.
Once approved for marketing, BioSig is entering into a global market for Electrophysiology EP devices will grow at a 12.1 percent a year to $5.5 billion by 2019, making it one of the fastest growing medical device segments. In the United States alone, the number of Atrial Fibrillation (AF) and Ventricular Tachycardia (VT) arrhythmia ablations is forecast to grow at 10.5 percent from 2012 to 2017(2).
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