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News 2026-09-28 15:58 UTC

Diagnos Inc. (ADK) Files FDA 513(g) for CARA System Classification

Diagnos Inc. submitted a Section 513(g) request to the U.S. FDA to determine classification and regulatory requirements for its CARA System, following prior FDA pre-submission.Material DetailsContext by AI AnalystThis is an early regulatory step in DIAGNOS’s push to commercialize CARA in the U.S. A…