BioSig Technologies (OTCQB: BSGM) said today it won FDA 510(k) clearance for its Pure EP electrophysiology system.
The Santa Monica, Calif.-based company said the PureEP system is designed for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing electrocardiographic and intracardiac signals for patients undergoing electrophysiology procedures.
The newly cleared system is intended to reduce noise and artifacts to produce high-fidelity cardiac signals, which the company claims could increase the diagnostic values of the signals.
Initial Pure EP systems were produced by Minnetronix, with a limited US launch at select sites planned, Biosig 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. We are excited to bring the advanced platform to the U.S. market,” chair & CEO Kenneth Londoner said in a press release.
