BioSig Technologies Announces FDA 510(k) Clearance for PURE EP System

BioSig Technologies (OTCQB:BSGM), announced that the Company has received 510(k) clearance for its first product, PURE EP System, from the U.S. Food and Drug Administration (FDA).

As quoted in the press release:

The non-invasive PURE EP System is a computerized system intended for acquiring, digitizing, 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 minimize 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.  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.  The Journal of Innovations in Cardiac Rhythm Management published several years of pre-clinical data (https://www.biosigtech.com/technology/publications) conducted at Mayo Clinic.

Click here to read the full press release.