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Medical Daily
Medical Daily
Cole Mercer

FDA Renamed and Updated Its Companion Diagnostics List, Including the First Test That Detects Cancer's Return in Blood

The FDA quietly updated the registry that decides which cancer patients are eligible for which targeted drugs, and it changed the list's name in the process.

The List of FDA-Authorized Companion Diagnostic Devices was updated and republished on July 23, 2026, according to the agency's Center for Devices and Radiological Health. It was previously titled the List of Cleared or Approved Companion Diagnostic Devices. The rename reflects that entries now arrive through several different regulatory routes, including premarket approval, 510(k) clearance, De Novo classification and humanitarian device exemption.

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