08:16 AM EST, 01/23/2025 (MT Newswires) -- Conavi Medical ( CNVIF ) on Thursday said a filing related to getting U.S. Food and Drug Administration clearance for its latest Novasight system, which enables intravascular imaging of coronary arteries, is targeted for the second half of this year, with a U.S. commercial launch planned for early 2026.

On approval, the company said it will begin placing Novasight systems at key U.S. hospitals on commercial terms as several have already expressed interest.

Conavi also plans to conduct the first-in-human study of the next-generation system early next year. This will be an important milestone marking the next-generation system's initial use in real-world clinical cases, it added.

"As we bring the next-generation Novasight to market, we're working to extend our technological advantage; initiatives include further integration of AI capabilities, achieving state-of-the-art image quality for both imaging modalities, and overcoming limitations in catheterization lab workflows," said CEO Tom Looby in a letter to shareholders. "Our goal is for these efforts to help support expansion beyond the US$700 million coronary (i.e., heart-based) segment to the broader interventional cardiology market, a potential US$4 billion market opportunity."