08:13 AM EDT, 09/16/2025 (MT Newswires) -- Conavi Medical ( CNVIF ) Tuesday said it has submitted its next generation Novasight intravascular imaging system to the U.S. Food and Drug Administration (FDA) for 510(k) clearance for coronary applications.

The 501(k) clearance is expected in the first half of next year with Conavi aiming for the U.S. commercial launch soon after.

Conavi's hybrid intravascular imaging platform combines both intravascular ultrasound (IVUS) and optical coherence tomography (OCT) into a single integrated system. This approach provides cardiologists with a comprehensive view of coronary arteries, potentially enabling more precise diagnosis and treatment of cardiovascular disease.

"The submission marks an important milestone for Conavi as we advance toward bringing our next-generation IVUS/OCT imaging solution to the U.S. market," said Tom Looby, chief executive officer.

"With our pilot system already cleared by the FDA, we feel that this submission leverages a strong regulatory foundation and may provide for an efficient review process."