Sept. 16, 2025 — Conavi Medical Corp., a commercial-stage medical device company focused on designing, manufacturing and marketing imaging technologies to guide minimally invasive cardiovascular procedures, announced it has submitted its next generation Novasight Hybrid IVUS/OCT intravascular imaging system to the U.S. Food and Drug Administration for 510(k) clearance for coronary applications. “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 of Conavi Medical. We believe the next-generation Novasight Hybrid system is well positioned to capitalize on the growing adoption of intravascular imaging, a category that has been shown to improve procedural outcomes during coronary interventions.”Conavi’s proprietary hybrid intravascular imaging platform uniquely combines both intravascular ultrasound (IVUS) and optical coherence tomography (OCT) into a single integrated system. Both the United States and Europe have recently adopted class IA guidelines recommending the use of IVUS or OCT for PCI procedural guidance. The European guidelines (ESC), released in August 2024, recommends that IVUS or OCT be used to guide PCIs in patients with complex lesions.