Diagnostics World News | Your Resource for Diagnostics …
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 …
IVD recent news | MDDI
Explore the latest news and expert commentary on IVD, brought to you by the editors of MDDI
Ivd News, Articles | clinicallab
Nov 12, 2024 · Discover key insights into how automated HPLC systems provide reliable A1c results with detection of commonly occurring hemoglobin variants for optimum management of …
CDRHNew - News and Updates | FDA
Dec 6, 2024 · Webinar - Registration & Listing Requirements for In Vitro Diagnostic Products (IVDs), Including Laboratory Developed Tests (LDTs) - 12/03/2024; Total Product Life Cycle …
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 …
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Intent to Initiate Reclassification Process for Most High Risk IVDs
As CDRH moves into 2024 and beyond, the Center intends to initiate the reclassification process for most IVDs that are currently class III (high risk) into class II (moderate risk). The majority...
LDT Oversight Gets Long-Awaited FDA Final Rule - MDDI Online
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. …
IVD news archivos - MDx | MedTech IVD CRO : MDx | MedTech IVD …
Dec 3, 2023 · FDA’s new LDT regulation underscores the vital role of IVD CROs in compliance and safety. Phased over four years without... read more. Introduction In the rapidly evolving …
MedTech and IVD News | MDx CRO : MDx | MedTech IVD CRO
Jun 22, 2024 · Stay up-to-date with the medical device world by following our blog on the latest MedTech and IVD news, trends and innovations. Learn more.
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