FDA clears Conavi hybrid IVUS-OCT imaging system

Conavi Medical has received FDA 510(k) clearance for its next-generation hybrid intravascular imaging system. The Toronto-based company said the system is designed to assess coronary anatomy within a single workflow.

The FDA database lists the cleared device as the Novasight Hybrid System under 510(k) K252945. The decision date was April 17, 2026.

The platform combines intravascular ultrasound and optical coherence tomography. Conavi said the system allows physicians to view deep vessel structures and high-resolution surface detail in real time.

The 510(k) record classifies the device as an intravascular ultrasound catheter system. The FDA lists it under the cardiovascular medical specialty.

The system is intended for intravascular imaging of coronary arteries in patients who are candidates for transluminal interventional procedures, according to the FDA 510(k) summary.

The system enables simultaneous, co-registered IVUS and OCT imaging in a single pullback. The company also said it includes lesion and stent analysis tools that use data from both modalities.

The company expects to begin a limited market release at select U.S. centers in the second half of 2026.