Ophthalmology
LumineticsCore (formerly IDx-DR)
Digital Diagnostics
FDACE
FDA-cleared AI medical device
First autonomous AI diagnostic device ever cleared in the United States — detects more-than-mild diabetic retinopathy from fundus photographs without a clinician reader.
FDA Submission Metadata
- Submission number
- DEN180001
- Decision date
- April 2018
- FDA panel
- Ophthalmic
- Product code
- PIB
This entry's identity, manufacturer, and clearance have been verified against primary regulatory sources. A full editorial deep-dive — performance, clinical evidence, and safety record — may follow.
Regulatory Approvals
FDA
US FDA De Novo
DEN180001
CE
EU CE MDR