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Special Communication
November 19, 2020

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

Author Affiliations
  • 1Byers Eye Institute, Stanford University, Stanford, California
  • 2Now with Vitreoretinal Surgery Fellowship Program, Duke Ophthalmology, Duke University School of Medicine, Durham, North Carolina
  • 3American Academy of Ophthalmology, San Francisco, California
  • 4American Academy of Optometry, Orlando, Florida
  • 5American Association for Pediatric Ophthalmology and Strabismus, San Francisco, California
  • 6American Glaucoma Society, San Francisco, California
  • 7American Optometric Association, St Louis, Missouri
  • 8American Society of Cataract and Refractive Surgeons, Fairfax, Virginia
  • 9American Society of Retinal Specialists, Chicago, Illinois
  • 10American Uveitis Society, Birmingham, Alabama
  • 11Cornea Society, Fairfax, Virginia
  • 12Center for Devices and Radiological Health Food and Drug Administration, Silver Spring, Maryland
  • 13Retina Society, Boston, Massachusetts
JAMA Ophthalmol. 2021;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.

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