Development, Validation, and Innovation in Ophthalmic Laser-Based Imaging: Report From a US Food and Drug Administration-Cosponsored Forum.
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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- United States Food and Drug Administration
- United States
- Tomography, Optical Coherence
- Technology Assessment, Biomedical
- Risk Factors
- Risk Assessment
- Predictive Value of Tests
- Patient Safety
- Ophthalmoscopy
- Ophthalmoscopes
Citation
Published In
DOI
EISSN
Publication Date
Volume
Issue
Start / End Page
Location
Related Subject Headings
- United States Food and Drug Administration
- United States
- Tomography, Optical Coherence
- Technology Assessment, Biomedical
- Risk Factors
- Risk Assessment
- Predictive Value of Tests
- Patient Safety
- Ophthalmoscopy
- Ophthalmoscopes