Terumo’s OpusWave Dual Sensor Imaging System and DualView Catheter Cleared by FDA

October 24, 2025—Terumo Interventional Systems, a division of Terumo Corporation, announced it has received FDA 510(k) clearance for its OpusWave dual sensor imaging system with the company’s DualView imaging catheter, which also received FDA 510(k) clearance.

According to Terumo, the OpusWave imaging system combines optical frequency domain imaging and intravascular ultrasound to enable simultaneous views, thereby allowing physicians to comprehensively evaluate coronary artery disease.

Terumo further stated that the OpusWave’s DualView imaging catheter offers a 150-mm maximum pullback length. It also has a 2.6-F imaging profile, 6-F guide compatibility. advanced hydrophilic coating, and a variable pullback speed of up to 40 mm/sec in dual mode.