FDA Clears Opsens' OptoWire and OptoMonitor FFR Products

June 15, 2015—Opsens Inc. announced 510(k) clearance from the US Food and Drug Administration for the OptoWire and OptoMonitor to measure fractional flow reserve (FFR). With the clearance, the company will market the OptoWire and OptoMonitor in the United States.

According to the company, the OptoWire is a nitinol-based optical guidewire for FFR that provides intracoronary blood pressure measurements with optical pressure guidewire technologies. The device’s immunity to the adverse effects related to blood contact allows easy and reliable connectivity that leads to reliable FFR measurements in extended conditions of use. The OptoWire is also designed to navigate coronary arteries and reach blockages with ease, stated Opsens.