However, "significant bottlenecks still exist," according to Dominika Suchonova, a spokesperson for MedTech Europe, a European association that represents IVD and medical device makers. Suchonova ...
In brief, LDTs are in vitro diagnostics (IVDs) that are intended for clinical use and are designed, manufactured, and used within laboratories that are certified under the Clinical Laboratory ...
The "Global IVD Raw Materials Market - Focused Insights 2024-2029" report has been added to ResearchAndMarkets.com's offering. The global IVD raw materials market is expected to reach a value of ...
The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter the landscape for laboratory-developed ...
Professional services consultancy, Procorre is urging the Medical Devices industry to take action ahead of the new ISO13485:2016 International Standard and MDD & IVD ‘Recast’ which become mandatory in ...
The evolving EU MDR and IVDR present key opportunities for companies to enhance compliance strategies, engage with notified bodies, and optimize market access. Staying informed and proactively ...
"We're proud to welcome CMC Medical Devices to the Registrar Corp family," said Raj Shah, CEO of Registrar Corp. "Together, we offer medical device manufacturers a single partner to navigate complex ...
Precision Dx Products include Twist Precision Prep and Enrichment Dx Kit, Twist Precision Exome Dx Panel and Twist Precision Exome Dx Kit SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Twist ...
WALTHAM, Mass. & SAN DIEGO--(BUSINESS WIRE)--Revvity, Inc. (NYSE: RVTY), today announced a strategic agreement to commercialize an in vitro diagnostic (IVD) workflow solution for neonatal sequencing, ...
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