The allowed claims address a system for determining the accuracy of an EP recorder or a mapping system in the acquisition of cardiac signals. The simulator is designed to generate digital or analog simulated waveforms for electrocardiograms, unipolar or bipolar electrograms or cardiac activation maps. The PURE EP Simulator has been previously evaluated for a commercialization pathway by Health Research International, Cleveland, Ohio. This patent should help the company move this system forward as a valuable additional technology in BioSig’s product pipeline to be marketed to U.S. hospital systems.
“We are delighted that our application for an electrophysiology simulator has been allowed by the U.S. Patent & Trademark Office. We believe that our system may become a valuable assistant in many research and clinical EP labs and may open doors to simulation-guided approaches to advance understanding of current arrhythmia therapies,” stated Kenneth L. Londoner, founder, chairman and CEO of BioSig Technologies Inc.
The PURE EP System is indicated as a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory under the supervision of licensed healthcare practitioners who are responsible for interpreting the data.
Previously, BioSig announced that it was allowed 33 patent claims covering its PURE EP System. In the first half of 2019, BioSig successfully conducted first patient cases using its PURE EP System at the Texas Cardiac Arrhythmia Institute in Austin, Greenville Memorial Hospital in Greenville, S.C., and Indiana University School of Medicine. These initial experiences suggested improved cardiac signal detection and fidelity compared to the data acquired using the existing recording devices in the EP lab.
BioSig Technologies is a medical technology company developing a proprietary biomedical signal processing platform designed to improve the electrophysiology (EP) marketplace. Led by a management team and a veteran Board of Directors, BioSig Technologies is preparing to commercialize its PURE EP System. The technology has been developed to address an unmet need in a large and growing market. The PURE EP System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory. The system is indicated for use under the supervision of licensed healthcare practitioners who are responsible for interpreting the data. This novel cardiac signal acquisition and display system is engineered to assist electrophysiologists in clinical decision-making during electrophysiology procedures in patients with abnormal heart rates and rhythms. BioSig’s ultimate goal is to deliver technology to improve upon catheter ablation treatments for the prevalent and potentially deadly arrhythmias, atrial fibrillation and ventricular tachycardia. BioSig has partnered with Minnetronix on technology development and received U.S. Food and Drug Administration 510(k) clearance for the PURE EP System in August 2018.