Development, Validation, and Innovation in Ophthalmic Laser-Based Imaging: Report From a US Food and Drug
Frank Brodie1,2, Michael Repka3, Stephen Allan Burns4
1Byers Eye Institute, Stanford University, Stanford, California.
JAMA Ophthalmology
|November 19, 2020
Summary
A 2019 forum focused on advancing laser-based ocular imaging technologies and artificial intelligence. The goal was to ensure US patients access innovative, safe, and effective ophthalmic medical devices first.
Area of Science:
- Ophthalmology and Vision Science
- Medical Device Innovation
- Biomedical Engineering
Background:
- A 2019 forum convened by the US Food and Drug Administration (FDA) and professional societies addressed laser-based imaging in ophthalmology.
- The event aimed to accelerate innovation and ensure timely patient access to advanced ophthalmic medical devices.
Framework:
- The forum explored technological advancements, clinical applications, and regulatory pathways for novel ocular imaging.
- It also examined reimbursement considerations for these innovative technologies.
Implementation:
- Key stakeholders including clinicians, researchers, industry, and regulatory bodies participated.
- Discussions focused on fostering collaboration to bring cutting-edge ophthalmic imaging solutions to market.
Implications:
- The integration of artificial intelligence in ophthalmic imaging was a significant topic, highlighting future directions.
- The conference outcomes are expected to guide the development and adoption of next-generation ophthalmic diagnostic tools.
