Diagnos Inc. Submits FDA Pre-Submission for CARA System, Aiming for Strategic Entry into U.S. Optometry Market with ORA LLC's Support
Reuters
Jul 16, 2025
<a href="https://laohu8.com/S/DGNOF">Diagnos Inc.</a> Submits FDA Pre-Submission for CARA System, Aiming for Strategic Entry into U.S. Optometry Market with ORA LLC's Support
Diagnos Inc., a leading Canadian company in artificial intelligence for early disease detection, has announced a significant milestone in its strategic expansion into the U.S. optometry market. The company has formally submitted a Pre-Submission (Q-sub) to the U.S. Food and Drug Administration (FDA) for its CARA System. This submission marks the first step towards obtaining regulatory clearance for the CARA System, a cloud-based platform designed to assist optometrists by analyzing retinal images for indicators of various retinal and systemic diseases. The initiative is supported by ORA LLC, known for their regulatory expertise and support in ophthalmic devices. This development positions Diagnos Inc. to enhance the efficiency and accuracy of eye care in the U.S., addressing a market with approximately 49,300 practicing optometrists.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Diagnos Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9495451-en) on July 16, 2025, and is solely responsible for the information contained therein.
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