Logos

Forum on Laser-Based Imaging Panel Questions

  1. FDA is seeking to promote innovation and expedite the clinical development of optical coherence tomographers (OCTs). As new functionalities are introduced, typically, performance data is compared to a gold standard. Does a gold standard comparator exist for the following:
    • a. Quantification of retinal vascularity?
    • b. Quantification of oximetry with visible light OCT?
    • c. Functional assessment of metabolic or indirect structure/blood flow changes?
    • d. AI-assisted segmentation?
  2. The addition of Adaptive Optics technology to imaging platforms (e.g., SLO and OCT) is currently under investigation, but not yet FDA cleared
    • a. Does AO technology introduce new concerns of:
    • i. Patient safety?
    • ii. Effectiveness?
  3. For cases where there is no clinical gold standard comparator for OCTs or AO-equipped imaging platforms, can adequate pre-clinical (animal model) and/or non-clinical software (i.e., synthetic images) or hardware (i.e., phantoms) comparators be created?
  4. What are the impediments to establishing reimbursement for new AO and OCT technologies?