Forum on Laser-Based Imaging Panel Questions
- 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?
- 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?
- 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?
- What are the impediments to establishing reimbursement for new AO and OCT technologies?