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Terumo announces US FDA clearance for OpusWave imaging system
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Cardiovascular NewsTerumo announces US FDA clearance for OpusWave imaging system
Terumo Interventional Systems has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its OpusWave dual-sensor imaging system, the company has announced. The system, which features the DualView imaging catheter, combines optical frequency domain imaging (OFDI) and intravascular ultrasound (IVUS) to enable simultaneous views and the ability to comprehensively evaluate coronary artery disease (CAD). The clearance marks T…
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