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CDRHNew - News and Updates | FDA
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 …
IVD recent news | MDDI
Ivd News, Articles | clinicallab
IVDNews
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...
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Intent to Initiate Reclassification Process for Most High Risk IVDs
Medical Device and Diagnostic industry
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 …
MedTech and IVD News | MDx CRO : MDx | MedTech IVD CRO
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