BioSig Technologies Inc (NASDAQ:BSGM) said Tuesday it has installed its PURE EP System at Massachusetts General Hospital (MGH) as part of an expanding clinical study.
The PURE EP System evaluation and data collection at MGH will commence under the leadership of investigator Dr Moussa Mansour, director of MGH’s Cardiac Electrophysiology Laboratory and Atrial Fibrillation Program.
“Bringing our technology to a major EP institution on the east coast is a definite milestone in our clinical development,” said BioSig CEO Kenneth Londoner in a statement. “We look forward to working with Dr Mansour and the entire MGH team as we pursue our mission of bringing advanced signal processing solutions to the field of electrophysiology.”
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The PURE (Precise Uninterrupted Real-time evaluation of Electrograms) EP System is a surface electrocardiogram and intracardiac multichannel recording and analysis system that displays electrocardiogram and electrograms required during electrophysiology studies and catheter ablation procedures.
BioSig is currently conducting patient cases under the clinical study titled, “Novel Cardiac Signal Processing System for Electrophysiology Procedures (PURE EP 2.0 Study)” at Texas Cardiac Arrhythmia Research Foundation in Austin, Texas and the Mayo Clinic in Jacksonville, Florida.
The Connecticut-based company received Institutional Review Board approvals to install its PURE EP System at several medical centers across the country for evaluation. All of these centers are high-volume clinical sites regarded for their work with new technologies.
“The market for atrial fibrillation is starting to open up again as patient cases are crucial for healthcare outcomes,” Londoner added.
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