Terumo Wins FDA Clearance for OPUSWAVE Dual Sensor Imaging System
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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.
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