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Conavi Medical Submits Next Generation Novasight Hybrid Intravascular Imaging System to US FDA for 510(k) Clearance
US FDA 510(k) Submission Follows the Successful Validation Testing with KOLs FDA 510(...
About this update from Conavi Medical Corp.
[{"type":"text","content":"Conavi Medical Submits Next Generation Novasight Hybrid Intravascular Imaging System to US FDA for 510(k) Clearance\n\n\n\n\n\n US FDA 510(k) Submission Follows the Successful Validation Testing with KOLs\n \n\n\n\n\n\n FDA 510(k) Clearance Anticipated During H1 2026 and Company Preparing for US Commercial Launch following Clearance\n \n\n\n\n\n\n Coronary Intravascular Imaging Market Expected to Grow to over $1 bil USD by 2028\n \n\n\n\n\n TORONTO, Sept. 16, 2025 (GLOBE NEWSWIRE) -- Conavi Medical Corp. (TSXV: CNVI) (OTCQB: CNVIF) (“Conavi” or the “Company”), a commercial-stage medical device company focused on designing, manufacturing, and marketing imaging technologies to guide minimally invasive cardiovascular procedures, announced that it has submitted its next generation Novasight Hybrid™ IVUS/OCT intravascular imaging system to the U.S. Food and Drug Administration (“FDA”) for 510(k) clearance for coronary applications.\n \n\n “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. “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. 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.”\n \n\n Conavi’s proprietary hybrid intravascular imaging platform uniquely combines both intravascular ultrasound (IVUS) and optical coherence tomography (OCT) into a single integrated system. This dual-modality approach is designed to provide cardiologists with a comprehensive view of coronary arteries, potentially enabling more precise diagnosis and treatment of cardiovascular disease.\n \n\n\n\n Key advancements in the next-generation Novasight Hybrid\n \n\n ™\n \n\n system include:\n \n\n\n\n\n Enhanced IVUS and OCT image quality\n \n\n Simplified user interface with added software features for improving ease of use\n \n\n System redesign to improve cath lab workflow including system se...