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. “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.”
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.
Key advancements in the Novasight Hybrid system include:
- Enhanced IVUS and OCT image quality
- Simplified user interface with added software features for improving ease of use
- System redesign to improve cath lab workflow including system setup and bedside control
- Design focus on reliability and robustness for routine clinical use
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 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. The US guidelines (ACC/AHA/SCAI), released in February 2025, recommends that IVUS or OCT be used to guide stent implantation in patients with Acute Coronary Syndrome (ACS) in complex lesions
For more information, visit conavi.com.
June 15, 2026 
