-+ 0.00%
-+ 0.00%
-+ 0.00%

Diagnos submits FDA 513(g) request for CARA System classification

PUBT·09/28/2026 15:57:09
Listen to the news
Diagnos submits FDA 513(g) request for CARA System classification
  • Diagnos filed an FDA Section 513(g) Request for Information for its CARA System, seeking device classification and U.S. regulatory requirements.
  • The filing follows an FDA Pre-Submission, reflecting the company’s push toward U.S. market access for the AI-assisted retinal imaging platform.


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: 202609281156PRIMZONEFULLFEED9835134) on September 28, 2026, and is solely responsible for the information contained therein.