BioSig Technologies have announced that the Company has received 510(k) clearance for its first product, PURE EP System, from the US Food and Drug Administration (FDA).
The non-invasive PURE EP System is a computerised system intended for acquiring, digitising, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory. The system is indicated for use under the supervision of licensed healthcare practitioners who are responsible for interpreting the data. The PURE EP System aims to minimise noise and artifacts, and acquire high-fidelity cardiac signals. Improving cardiac signals may potentially increase the diagnostic value of these signals, thereby possibly improving accuracy and efficiency of the EP studies and related procedures.
To date, BioSig has performed twelve pre-clinical studies at Mayo Clinic in Rochester, MN, three at UCLA Medical Center in Los Angeles, CA, and one at Mount Sinai Hospital in New York, NY (all USA). BioSig signed a 10-year collaboration agreement with Mayo Clinic in 2017 that will enable the Company to advance the platform and expand its capabilities into other areas of clinical importance.
Minnetronix, BioSig’s manufacturing partner in St. Paul, USA, has produced initial systems that will allow the Company to enter the market in the USA with selected sites.
“Our PURE EP System is the culmination of many years of scientific research and business development efforts. It is our goal to provide tangible benefits to electrophysiologists and improve the current standards of EP procedures in the clinical setting. We are excited to bring the advanced platform to the U.S. market,” commented Kenneth L Londoner, Chairman and CEO of BioSig Technologies, Inc.