Conavi Medical Submits Next Generation Novasight Hybrid Intravascular Imaging System to US FDA for 510(k) Clearance

Core Viewpoint - Conavi Medical Corp. has submitted its next-generation Novasight Hybrid™ IVUS/OCT intravascular imaging system to the FDA for 510(k) clearance, marking a significant step towards U.S. market entry [1][2] Company Overview - Conavi Medical focuses on designing, manufacturing, and marketing imaging technologies for minimally invasive cardiovascular procedures [4] - The Novasight Hybrid™ System is the first to integrate intravascular ultrasound (IVUS) and optical coherence tomography (OCT) into a single device, allowing simultaneous imaging of coronary arteries [4] Product Advancements - The next-generation Novasight Hybrid™ system features enhanced IVUS and OCT image quality, a simplified user interface, and a redesign aimed at improving workflow in cath labs [7] - The system is designed for reliability and robustness for routine clinical use [7] Market Context - The intravascular imaging market is expected to exceed $1 billion by 2028, driven by the increasing adoption of advanced imaging technologies [6] - Recent guidelines from both the U.S. and Europe recommend the use of IVUS or OCT for guiding percutaneous coronary interventions (PCI), indicating a growing acceptance of these technologies [3]