Development, Validation, and Innovation in Ophthalmic Laser-Based Imaging: Report From a US Food and Drug Administration-Cosponsored Forum

JAMA Ophthalmol. 2021 Jan 1;139(1):113-118. doi: 10.1001/jamaophthalmol.2020.4994.

Abstract

In April 2019, the US Food and Drug Administration, in conjunction with 11 professional ophthalmic, vision science, and optometric societies, convened a forum on laser-based imaging. The forum brought together the Food and Drug Administration, clinicians, researchers, industry members, and other stakeholders to stimulate innovation and ensure that patients in the US are the first in the world to have access to high-quality, safe, and effective medical devices. This conference focused on the technology, clinical applications, regulatory issues, and reimbursement issues surrounding innovative ocular imaging modalities. Furthermore, the emerging role of artificial intelligence in ophthalmic imaging was reviewed. This article summarizes the presentations, discussion, and future directions.

Publication types

  • Congress
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Artificial Intelligence
  • Diffusion of Innovation
  • Eye / diagnostic imaging*
  • Eye Diseases / diagnostic imaging*
  • Humans
  • Image Interpretation, Computer-Assisted
  • Lasers* / adverse effects
  • Ophthalmoscopes* / adverse effects
  • Ophthalmoscopy* / adverse effects
  • Patient Safety
  • Predictive Value of Tests
  • Risk Assessment
  • Risk Factors
  • Technology Assessment, Biomedical*
  • Tomography, Optical Coherence / adverse effects
  • Tomography, Optical Coherence / instrumentation*
  • United States
  • United States Food and Drug Administration