Conavi Medical Corp. 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 follows successful validation testing with key opinion leaders and positions the company for anticipated FDA clearance during the first half of 2026.
"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."
Hybrid Imaging Technology Addresses Clinical Need
Conavi's proprietary 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.
The next-generation system incorporates several key advancements over the previous version, including enhanced IVUS and OCT image quality, a simplified user interface with added software features for improving ease of use, and system redesign to improve catheterization laboratory workflow including system setup and bedside control. The design also focuses on reliability and robustness for routine clinical use.
Growing Market Supported by Updated Guidelines
The intravascular imaging market continues to grow, driven by increasing global adoption of advanced imaging to optimize stent placement and improve clinical outcomes. Both the United States and Europe have recently adopted class IA guidelines recommending the use of IVUS or OCT for percutaneous coronary intervention (PCI) procedural guidance.
The European guidelines from the European Society of Cardiology, released in August 2024, recommend that IVUS or OCT be used to guide PCIs in patients with complex lesions. The U.S. guidelines from the American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography & Interventions, released in February 2025, recommend that IVUS or OCT be used to guide stent implantation in patients with Acute Coronary Syndrome in complex lesions.
The coronary intravascular imaging market is expected to grow to over $1 billion by 2028, according to the company.
Validation Testing and Clinical Evidence
In July 2025, Conavi conducted two pre-clinical animal experiments with several leading interventional cardiologists, confirming that the next-generation Novasight meets key customer specifications for usability, imaging performance, and workflow integration. These studies validated market readiness and established that the system is competitive with best-in-class stand-alone IVUS and OCT solutions.
A recent publication in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI) featured a case study with images from the first-generation Novasight system, highlighting hybrid IVUS/OCT imaging as a breakthrough modality for guiding complex coronary interventions.
Commercial Preparation and Financial Position
Conavi completed a $20 million financing in April 2025, led by U.S. institutional investors, which strengthens the company's balance sheet and supports the anticipated U.S. launch. The company is advancing preparations to transition the next-generation Novasight from development to manufacturing, with transfer to production expected to be completed to coincide with the planned U.S. launch in the first half of 2026.
The first-generation Novasight Hybrid™ System currently has regulatory clearance in the U.S., Canada, China, and Japan. Looby noted that the company believes the next-generation 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."
