Technology | EP Mapping and Imaging Systems | August 14, 2018

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

Electrophysiology mapping system minimizes noise and artifacts in ECG and intracardiac signals during EP procedures

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

August 14, 2018 — BioSig Technologies Inc. announced that the company received 510(k) clearance for its first product, Pure EP System, from the U.S. Food and Drug Administration (FDA).  

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, Minn.;
  • Three at UCLA Medical Center in Los Angeles; and
  • One at Mount Sinai Hospital in New York.

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.

Minnetronix, BioSig’s manufacturing partner in St. Paul, Minn., has produced initial systems that will allow the company to enter the market in the U.S. with selected sites.

One of the most common reasons for an EP procedure is the diagnosis and treatment of atrial fibrillation. Atrial fibrillation is the most common arrhythmia, currently affecting 33.5 million people worldwide, with 6.1 million people in the U.S. Atrial fibrillation increases the risk of stroke by 4 to 5 times and contributes to approximately 750,000 hospitalizations per year. According to the 2016 HRI Global Opportunities in Medical Devices & Diagnostics report, the current market of EP is estimated at $4.6 billion and growing at a 10.5 percent rate annually.

On Aug. 1, BioSig Technologies announced its intention to uplist to the Nasdaq exchange. The company expects to be trading on Nasdaq in 2018.

For more information: www.biosigtech.com

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