October 29, 2025- Terumo Interventional Systems (TIS) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its OPUSWAVE® Dual Sensor Imaging System. The OPUSWAVE Imaging System features the DualView® imaging catheter, which also received FDA 510(k) clearance. The OPUSWAVE Imaging System combines Optical Frequency Domain Imaging (OFDI) and intravascular ultrasound (IVUS) to enable simultaneous views, offering physicians the ability to comprehensively evaluate coronary artery disease (CAD).