Conavi submits Novasight imaging system to FDA

Executive Summary

• Conavi Medical Corp. has submitted its next-generation Novasight Hybrid IVUS/OCT intravascular imaging system to the U.S. FDA for 510(k) clearance for coronary applications.
• The submission leverages a strong regulatory foundation, as the pilot system is already cleared by the FDA, potentially allowing for an efficient review process.
• The new system combines intravascular ultrasound (IVUS) and optical coherence tomography (OCT) into a single integrated platform to provide cardiologists with comprehensive coronary artery views.

Key Details

• Submission Type: 510(k) clearance to the U.S. Food and Drug Administration (FDA).
• Product: Next-generation Novasight Hybrid IVUS/OCT intravascular imaging system.
• Indication: Coronary applications.
• Key Advancements in Next-Generation System:
  • Enhanced IVUS and OCT image quality.
  • Simplified user interface with added software features for improved 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.
• Market Context:
  • The intravascular imaging market is growing due to increased global adoption of advanced imaging to optimize stent placement and improve clinical outcomes.
  • European Guidelines (ESC): Released August 2024, recommending IVUS or OCT for guiding PCIs in patients with complex lesions.
  • U.S. Guidelines (ACC/AHA/SCAI): Released February 2025, recommending IVUS or OCT for guiding stent implantation in patients with Acute Coronary Syndrome (ACS) in complex lesions.
• Company Background:
  • Conavi Medical designs, manufactures, and markets imaging technologies for minimally invasive cardiovascular procedures.
  • The first-generation Novasight Hybrid system is the first to combine IVUS and OCT into a single device for simultaneous and co-registered imaging.
  • The first-generation system holds regulatory clearance in the United States, Canada, China, and Japan.

Notable Quotes

• "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... 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." — Tom Looby, Chief Executive Officer