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

Frank Brodie, Michael Repka, Stephen Allan Burns, S. Grace Prakalapakorn, Christie Morse, Joel S. Schuman, Michael R. Duenas, Natalie Afshari, John S. Pollack, Jennifer E. Thorne, Albert Vitale, H. Nida Sen, David Myung, Mark S. Blumenkranz, Elmer Tu, Daniel X. Hammer, Michelle Tarver, Bradley Cunningham, Larry Kagemann, Srini Vas SaddaDavid Sarraf, Glenn J. Jaffe, Malvina Eydelman

    Research output: Contribution to journalReview articlepeer-review

    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.

    Original languageEnglish (US)
    Pages (from-to)113-118
    Number of pages6
    JournalJAMA ophthalmology
    Volume139
    Issue number1
    DOIs
    StatePublished - Jan 2021

    ASJC Scopus subject areas

    • Ophthalmology

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