About 84,600 results
Open links in new tab
  1. CDRHNew - News and Updates | FDA

  2. Diagnostics World News | Your Resource for …

    Here are the top stories of Diagnostic World News and thoughts from industry leaders. More. Dec 27 | Diagnostics World | PathAI launches the AIM-IHC Breast Panel; electronRx plans purpleDx, a cardiopulmonary assessment app; and …

  3. IVD recent news | MDDI

  4. Ivd News, Articles | clinicallab

  5. IVDNews

  6. The top IVD innovation news stories of 2023 — so far

    Jun 14, 2023 · Here are five IVD innovation stories that have caught our attention so far this year: 5. Hologic wins FDA clearance for COVID-flu-RSV assay. Last winter, the U.S. and other countries...

  7. People also ask
  8. Intent to Initiate Reclassification Process for Most High Risk IVDs

  9. Medical Device and Diagnostic industry

  10. LDT Oversight Gets Long-Awaited FDA Final Rule

    Apr 30, 2024 · FDA has updated regulations to classify LDTs as medical devices under the FD&C Act, impacting oversight. FDA plans a four-year phase-out of enforcement discretion for LDTs. While IVD manufacturers welcome the …

  11. MedTech and IVD News | MDx CRO : MDx | MedTech IVD CRO

  12. Some results have been removed