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BioSig Technologies Inc (NASDAQ: BSGM), a medical device company, announced Friday a commercial milestone with respect to its FDA-approved PURE EP Systems.
What Happened: Westport, Connecticut-based BioSig said it sold three PURE EP Systems to St. David's HealthCare of Austin, Texas.
The PURE EP System is a proprietary signal acquisition and processing technology that is used for acquiring and storing electrocardiographic and intracardiac signals for patients undergoing electrophysiology procedures in a lab under the supervision of licensed health care practitioners who are responsible for interpreting the data.
The PURE EP System received FDA 510(k) market clearance in August 2018. A 510(k) clearance is given by the FDA to signal the device in question is substantially equivalent to a predicate device, such as a product already cleared for sale in the U.S.
Why It's Important: BioSig installed the first PURE EP System at St. David's Medical Center in November 2019, as part of a clinical trial, with the center's Texas Cardiac Arrhythmia Institute conducting the first patient cases.
To date, more than 400 patient procedures have been conducted with the PURE EP System across six clinical sites in the U.S., BioSig said.
"Our first commercial sale to St. David's HealthCare is another important milestone as we proceed in expanding our clinical footprint nationwide," CEO Kenneth Londoner said in a statement.
"This installation cements our valued relationship with St. David's and adds to the traction we are gaining in the electrophysiology (EP) market."
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