Report ID: SQMIG35A2516
Report ID:
SQMIG35A2516 |
Region:
Global |
Published Date: March, 2024
Pages:
219
|
Tables:
63 |
Figures:
75
In June 2023 Eyenuk received FDA clearance for its Topcon NW400 retinal camera with its EyeArt AI system for the autonomous AI detection of diabetic retinopathy.
In January 2023, Eyenuk received European Union Medical Device Regulation (MDR) certification for its EyeArt AI eye screening system. This certification covers the detection of diabetic retinopathy, age-related macular degeneration, and glaucoma.
In June 2022, Regeneron Pharmaceuticals, Inc. announced that the US Food and Drug Administration (FDA) has accepted for update the EYLEA (aflibercept) The injection supplemental Biologics License Use (sBLA) for every 16-week 2 mg dosage regimen (after initial every month doses) in patients in diabetic retinopathy (DR).
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Report ID: SQMIG35A2516