FDA Clears Hybrid System that Combines Intravascular Ultrasound with Optical Coherence Tomography

The Food and Drug Administration (FDA) has granted 510(k) clearance for a new device that offers a hybrid combination of intravascular ultrasound (IVUS) and optical coherence tomography (OCT).

Conavi Medical, the developer of the hybrid IVUS/OCT system, said the AI-enabled platform provides an array of key benefits:

• simultaneous access to co-registered IVUS and OCT imaging in a single pullback;

• streamlined catheter connection workflow; and

• tools that combine lesion and stent analysis insights from IVUS and OCT.

The combination of these features gives clinicians enhanced real-time visualization of both high-resolution surface detail as well as deep vessel structures, according to Conavi Medical.

“Hybrid IVUS-OCT imaging has the potential to meaningfully enhance how we approach complex coronary interventions,” said Megha Prasad, MD, an 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.”