FDA Clears Conavi’s Hybrid IVUS-OCT Imaging System

Conavi Medical has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its next-gen hybrid imaging system, which was designed to provide a more complete assessment of coronary anatomy in a single workflow.

The company’s next-gen hybrid imaging system combines intravascular ultrasound (IVUS) and optical coherence tomography (OCT) into one platform. Together, these technologies let physicians visualize both deep vessel structures (IVUS) and high-resolution surface detail (OCT) in one platform.

Intravascular imaging is becoming more recognized as a critical tool in percutaneous coronary intervention (PCI). It has growing clinical evidence showing improved outcomes when imaging is leveraged to guide stent sizing and placement. However, the technology is underutilized globally because of workflow complexity and needing to use multiple imaging systems.

Conavi’s system enables simultaneous, co-registered IVUS and OCT image in a single pullback, providing lesion and stent analysis tools the use insights from both imaging modalities. A streamlined catheter connection workflow was designed for ease of use and the catheter design focuses on enhanced deliverability.

“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, 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. 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.”

The company expects to begin a limited market release in select U.S. centers in the second half of this year.

“Hybrid IVUS-OCT imaging has the potential to meaningfully enhance how we approach complex coronary interventions,” said Dr. Megha Prasad, interventional cardiologist at New York-Presbyterian Hospital. “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.”