BioSig Technologies Inc. said the U.S. Food and Drug Administration approved its first product, the PURE EP System.
The Los Angeles-based medical device maker said the 510(k) clearance was granted for the PURE EP System, which records and calculates, among other things, electrocardiographic and intracardiac signals for patients undergoing electrophysiology procedures in a laboratory.
The system is indicated for use under the supervision of licensed healthcare practitioners who are responsible for interpreting the data.
One of the most common reasons for an electrophysiology procedure is the diagnosis and treatment of atrial fibrillation, an abnormal heart rhythm characterized by a rapid and irregular beating of the atria.
Atrial fibrillation affects 6.1 million people in the U.S., increasing their risk of stroke by 4 to 5 times.
In addition, the company expects its uplisting to Nasdaq to happen in 2018.