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.
Related story "BioSig’s Device Aims for Arrhythmia Market"
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 firstname.lastname@example.org. Follow him on Twitter @_DanaBart.
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