BioSig Technologies Inc., a medical device firm based in West Los Angeles, announced Aug. 14 it had received federal clearance to sell a signal processing platform to assist cardiologists.
The U.S. Food and Drug Administration has given the go-ahead to market the company’s Pure EP System, a biomedical device that that helps cardiologists perform catheter ablation, a procedure that can lessen arrhythmias.
BioSig, founded in 2009, aims at entering the $4.6 billion global market for electrophysiology, which uses catheters to neutralize areas of the heart that can cause irregular heartbeats.
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The company has performed 12 pre-clinical studies of its Pure EP at the Mayo Clinic in Minnesota, UCLA Medical Center and Mount Sinai Hospital in New York. It signed a 10-year licensing agreement with Mayo Clinic last year for its joint development.
BioSig has raised at least $35 million in funding to date, but posted a loss of $12.8 million last year. This month, it announced its intention to uplist to the Nasdaq Stock Exchange.
Health business reporter Dana Bartholomew can be reached at email@example.com. Follow him on Twitter @_DanaBart.