Conavi’s IVUS-OCT System for Intravascular Imaging Cleared by FDA

April 21, 2026—Conavi Medical Corp., a developer of imaging technologies to guide common minimally invasive cardiovascular procedures, announced that it has received FDA 510(k) clearance for its next-generation hybrid imaging system. The company stated it expects to initiate a limited market release of the system in select centers in the United States in the second half of 2026.

According to Cornavi, the new system integrates intravascular ultrasound (IVUS) and optical coherence tomography (OCT) into a single platform for a complete assessment of coronary anatomy. Together, these technologies enable physicians to visualize both deep vessel structures (IVUS) and high-resolution surface detail (OCT) in real time to support physician decision making and streamline workflows, noted the company.

As outlined in Conavi’s press release, the next-generation hybrid imaging system enables simultaneous, coregistered IVUS and OCT imaging in a single pullback; provides lesion and stent analysis tools that incorporate insights from both imaging modalities; and enables streamlined catheter connection workflow designed for ease of use.

“Hybrid IVUS-OCT imaging has the potential to meaningfully enhance how we approach complex coronary interventions,” commented Megha Prasad, MD, in the company’s press release.

Dr. Prasad who is an interventional cardiologist at New York-Presbyterian Hospital in New York, New York, continued, “The ability to simultaneously evaluate plaque composition, vessel size, and stent expansion in a single pullback can support procedural decision-making and workflow efficiency. Technologies like Conavi’s next-generation hybrid system are helping move the field toward more precise, image-guided care, and I look forward to using it regularly in my practice.”