TY - JOUR
T1 - Development, Validation, and Innovation in Ophthalmic Laser-Based Imaging
T2 - Report from a US Food and Drug Administration-Cosponsored Forum
AU - Brodie, Frank
AU - Repka, Michael
AU - Burns, Stephen Allan
AU - Prakalapakorn, S. Grace
AU - Morse, Christie
AU - Schuman, Joel S.
AU - Duenas, Michael R.
AU - Afshari, Natalie
AU - Pollack, John S.
AU - Thorne, Jennifer E.
AU - Vitale, Albert
AU - Sen, H. Nida
AU - Myung, David
AU - Blumenkranz, Mark S.
AU - Tu, Elmer
AU - Hammer, Daniel X.
AU - Tarver, Michelle
AU - Cunningham, Bradley
AU - Kagemann, Larry
AU - Sadda, Srini Vas
AU - Sarraf, David
AU - Jaffe, Glenn J.
AU - Eydelman, Malvina
N1 - Funding Information:
reported serving as a consultant and board member for Notal Vision, as well as owning stock options in Notal Vision. Dr Sarraf reported grants from Amgen, Genentech, and Regeneron; personal fees from Bayer and Novartis; nonfinancial support (research equipment grants) from Heidelberg and Topcon; and consultant fees, research equipment grants, and speaker fees from Optovue outside the submitted work. Dr Schuman report serving as a consultant/advisor to Aerie Pharmaceuticals Inc, Ocugenix, Ocular Therapeutix Inc, Opticient, and SLACK Incorporated; receiving grants from BrightFocus Foundation National Eye Institute; receiving patents or royalties from Carl Zeiss Meditec and Ocugenix; and being an equity owner of Ocular Therapeutix, Inc. Dr Brodie reported a patent pending to peripheral retinal OCT. Dr Repka reported serving as medical director for government affairs at the American Academy of Ophthalmology, interacting in that role with US Food and Drug Administration officials. Dr Prakalapakorn reported nonfinancial support from American Association for Pediatric Ophthalmology and Strabismus during the conduct of the study. Dr Schuman reported personal fees from Carl Zeiss Meditec outside the submitted work; in addition, Dr Schuman had patents to 9,514,513, 7,992,999, 10,575,723 B2, 8,831,304, US 8,184.885 B2, 8,712,505 B2, US 8,911,089 B2, US 10,136,808 B2, US 9,844,315 B2, 5,459,570, and 5,321,501 issued, as well as a patent to US 2018/0158182 A1 pending. Dr Thorne reported personal fees from AbbVie and Gilead and grants from Santen, the National Eye Institute, and Research to Prevent Blindness outside the submitted work. Dr Blumenkranz reported being health director with associated equity interest at Verana outside the submitted work; in addition, Dr Blumenkranz had a patent issued as a coauthor of Stanford University smartphone imaging (property of Stanford University). Dr Sadda reported personal fees and nonfinancial support from Heidelberg, Nidek, Carl Zeiss Meditec, Optos, and Centervue; nonfinancial support from Topcon; and personal fees from Allergan, Genentech/Roche, Regeneron, Novartis, and Merck outside the submitted work. No other disclosures were reported.
Publisher Copyright:
© 2021 American Medical Association. All rights reserved.
PY - 2021/1
Y1 - 2021/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85096718884&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85096718884&partnerID=8YFLogxK
U2 - 10.1001/jamaophthalmol.2020.4994
DO - 10.1001/jamaophthalmol.2020.4994
M3 - Review article
C2 - 33211074
AN - SCOPUS:85096718884
SN - 2168-6165
VL - 139
SP - 113
EP - 118
JO - JAMA Ophthalmology
JF - JAMA Ophthalmology
IS - 1
ER -