Terumo Wins FDA Clearance for OPUSWAVE Dual Sensor Imaging System
Terumo Interventional Systems has received FDA 510(k) clearance for its OPUSWAVE® Dual Sensor Imaging System and DualView® imaging catheter. This system combines Optical Frequency Domain Imaging (OFDI) and intravascular ultrasound (IVUS) in one catheter, allowing for simultaneous evaluation of coronary artery disease. This marks Terumo's entry into the U.S. imaging market.
Terumo Interventional Systems, a division of Terumo Corporation, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its OPUSWAVE® Dual Sensor Imaging System and the DualView® imaging catheter. The OPUSWAVE Imaging System uniquely combines Optical Frequency Domain Imaging (OFDI) and intravascular ultrasound (IVUS) into a single catheter, offering physicians simultaneous views to comprehensively evaluate coronary artery disease. This FDA clearance marks Terumo’s imaging debut in the U.S. market. No grant or funding from multiple organizations is mentioned. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Terumo Corporation published the original content used to generate this news brief via PR Newswire (Ref. ID: CN00220) on October 24, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT)
