Conavi Medical has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance for its next-generation hybrid coronary imaging system.
The milestone positions the company to initiate its US commercial launch expected in the second half of 2026 and to expand its hybrid intravascular imaging technology.
The Conavi system integrates intravascular ultrasound (IVUS) and optical coherence tomography (OCT) technologies into a single platform. Combining these two systems enables physicians to visualise both deep vessel structures and high-resolution surface detail in real time. It is designed to support physician decision making and streamline workflows, the company says in a press release.
“FDA clearance of our next-generation hybrid imaging system marks a pivotal moment for Conavi as we transition into commercial launch in the USA,” said Thomas Looby, CEO 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.”
“Hybrid IVUS-OCT imaging has the potential to meaningfully enhance how we approach complex coronary interventions,” said Megha Prasad (New York-Presbyterian Hospital, New York, USA). “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.”
