FDA clears BioSig system for high-fidelity heart rhythm exams

EKG rhythm
The FDA clearance follows a $4.28 million private stock placement, as the company looks to be uplisted to the Nasdaq. (Pixabay/PublicDomainPictures)

BioSig Technologies received a 510(k) clearance from the FDA for its first product, the PURE EP system, a noninvasive platform for digitizing and analyzing electrocardiographic and intracardiac signals for patients undergoing electrophysiology procedures.

The computerized system aims to minimize noise and artifacts while acquiring high-fidelity cardiac signals, with the goal of improving an exam's diagnostic value by providing a clearer picture for interpretation by healthcare providers.

EP procedures are commonly used to diagnose and treat abnormal heart rhythms such as atrial fibrillation, the most common arrhythmia, which affects 33.5 million worldwide, with 6.1 million of those in the U.S., the company said.

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“Our PURE EP System is the culmination of many years of scientific research and business development efforts,” BioSig Chairman and CEO Kenneth Londoner said in a statement. “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.”

BioSig also closed a private stock placement of nearly $4.3 million, which priced unregistered common stock at $2.28, bringing its 2018 fundraising total to about $11 million, following placements in February and May.

Following a recent application to uplist on the Nasdaq, BioSig said it believes it has met the final listing requirement of minimum shareholder equity with the latest raise. During the review process, the company’s common stock will continue to be traded on the OTC market under its current symbol, BSGM.

“This latest placement has brought us to our strongest financial position since the company’s foundation in February 2009. We have been building a very strong and loyal base of shareholders since going public in October 2014,” Londoner said, adding that the Santa Monica, California-based company’s top 25 shareholders control about 70% of its shares.