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Conavi Medical Announces FDA 510(k) Clearance of its Next-Generation Hybrid IVUS-OCT System for Intravascular Imaging

DateApril 20, 2026
CategoriesCohort News
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TORONTO, April 20, 2026 — Conavi Medical Corp., a commercial stage medical device company focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its next-generation hybrid imaging system, designed to deliver a more complete assessment of coronary anatomy within a single workflow. The milestone positions the Company to initiate its U.S. commercial launch expected in calendar H2 2026 and to expand its hybrid intravascular imaging technology.

Conavi’s next-generation hybrid imaging system integrates intravascular ultrasound (IVUS) and optical coherence tomography (OCT) into a single platform. These technologies together enable physicians to visualize both deep vessel structures (IVUS) and high-resolution surface detail (OCT) in real time. It is designed to support physician decision making and streamline workflows.

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