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Conavi Medical Announces FDA 510(k) Clearance of its Next-Generation Hybrid IVUS-OCT System for Intravascular Imaging
- First co-registered and co-aligned IVUS-OCT Platform for Intravascular Imaging  - Compan...
About this update from Conavi Medical Corp.
[{"type":"text","content":"Conavi Medical Announces FDA 510(k) Clearance of its Next-Generation Hybrid IVUS-OCT System for Intravascular Imaging\n- First co-registered and co-aligned IVUS-OCT Platform for Intravascular Imaging - Company Positioned for U.S. Commercial Launch in a Growing Intravascular Imaging Market Estimated at Over $1 Billion TORONTO, April 20, 2026 (GLOBE NEWSWIRE) -- 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. “FDA clearance of our next-generation hybrid imaging system marks a pivotal moment for Conavi as we transition into commercial launch in the U.S.,” said Thomas Looby, Chief Executive Officer of Conavi Medical. “We believe hybrid IVUS-OCT imaging represents the next evolution in intravascular imaging, bringing together IVUS and OCT into a single system to give a complete picture of the vessel. With this clearance, we are focused on executing our U.S. commercial launch expected in calendar H2 2026, supporting physician decision-making during these procedures, and driving adoption in leading U.S. centers. This clearance reflects years of focused work by an exceptional team across engineering, clinical, regulatory, and operations, and would not have been possible without the trust of our clinical investigators, the commitment of our manufacturing and supply partners, and the continued support of our shareholders.” “Hybrid IVUS-OCT imaging has the potential to meaningful...