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

Journal Article

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.

Full Text

Duke Authors

Cited Authors

  • Brodie, F; Repka, M; Burns, SA; Prakalapakorn, SG; Morse, C; Schuman, JS; Duenas, MR; Afshari, N; Pollack, JS; Thorne, JE; Vitale, A; Sen, HN; Myung, D; Blumenkranz, MS; Tu, E; Hammer, DX; Tarver, M; Cunningham, B; Kagemann, L; Sadda, S; Sarraf, D; Jaffe, GJ; Eydelman, M

Published Date

  • January 1, 2021

Published In

Volume / Issue

  • 139 / 1

Start / End Page

  • 113 - 118

PubMed ID

  • 33211074

Pubmed Central ID

  • PMC8005310

Electronic International Standard Serial Number (EISSN)

  • 2168-6173

Digital Object Identifier (DOI)

  • 10.1001/jamaophthalmol.2020.4994


  • eng

Conference Location

  • United States