Optical Surgical Navigation (OSN) Workshop: Discovery to Clinical Acceptance Part 1

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About Course

The Optical Surgical Navigation workshop will highlight experts from various institutions to discuss ongoing clinical trials and developments in the field of intraoperative molecular imaging. This workshop will focus on clinical trial design considerations and advancing regulatory guidance.  The second session of this workshop is facilitated by representatives from the US Food and Drug Administration (FDA). The FDA experts will lead discussions aimed at providing invaluable insights into regulatory pathways, fostering a deeper understanding of essential considerations in clinical trial design, and addressing pertinent queries regarding the support required from the FDA for clinical translation.

By the conclusion of the workshop sessions, participants will be updated on the progress of new research and the progress of clinical trials and will gain a deeper understanding of regulatory requirements, clinical trial design principles, and the critical role of FDA support in facilitating the development and commercialization of surgical navigation technologies. Armed with newfound insights and guidance, participants will be better equipped to navigate regulatory pathways and design robust clinical trials.

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Course Content

Using Spontaneous Large Animal Models of Cancer to Test Near-Infrared Imaging Strategies

  • Using Spontaneous Large Animal Models of Cancer to Test Near-Infrared Imaging Strategies
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Updates on Clinical Trials of the Nerve Imaging Agent ALM-488 in Patients Undergoing Head and Neck Surgery

Real-time diagnosis of necrotizing soft-tissue infections using indocyanine green kinetic modeling

Industrial perspective on the clinical development of a tumor-specific marker for fluorescence-guided surgery: regulatory and market specificities