BioSig Technologies, a medical device firm, has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Pure EP cardiac signal acquisition and display system.
Image: The US FDA’s Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.
The new computerized system will help electrophysiologists in clinical decision making during procedures to diagnose and treat patients with abnormal heart rates and rhythms.
It has been developed 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 medical device firm said that Pure EP system has to be used under the supervision of licensed healthcare practitioners. It aims to minimize noise and artifacts, as well as captures high-fidelity cardiac signals.
The enhanced cardiac signals will help increase the diagnostic value of these signals, and improve accuracy and efficiency of the EP studies and related procedures.
To prove the efficiency of Pure EP system, the firm has carried out 12 pre-clinical studies at Mayo Clinic in Rochester, three at UCLA Medical Center in Los Angeles and one at Mount Sinai Hospital in New York.
In 2017, BioSig also entered into a 10-year collaboration agreement with Mayo Clinic to advance the platform and extend its capabilities into other areas.
BioSig’s manufacturing partner Minnetronix has produced initial systems, which will be marketed at selected locations in the US.
BioSig Technologies chairman and CEO Kenneth Londoner said: “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.”
Atrial fibrillation is said to be the most common arrhythmia, which is currently affecting 33.5 million people across the globe, while 6.1 million people in the US.
As per the 2016 HRI Global Opportunities in Medical Devices & Diagnostics report, the present market of EP is estimated at $4.6bn and increasing at 10.5% rate annually.
BioSig Technologies is engaged in the development of an advanced biomedical signal processing technology for the EP market.