The introduction of new Post-Market Surveillance regulations and UKCA marking processes presents key opportunities for medical device manufacturers to align compliance strategies and enhance market ...

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The UKCA mark was introduced in the Great British (GB) market to replace the European CE mark following Brexit. Products which require a CE mark in the EU must comply with the UKCA marking regime if ...

As previously announced, the UK government has enacted legislation to continue the recognition of the CE marking indefinitely for a range of products falling within the scope of 21 regulations, ...

The UK government recently announced an indefinite extension to the use of CE marking for most goods. The extended recognition of CE marking does not, however, apply to medical devices. That said, the ...

SPINEstat™, a novel, first-in-class diagnostic blood test for axial spondyloarthritis (axSpA), has received UKCA marking and is now listed as an IVD in the United Kingdom. This milestone expands ...

LAKE FOREST, Calif.--(BUSINESS WIRE)--Genomic Testing Cooperative (GTC) today announced it received UKCA marks for its Hematology Profile Plus, Solid Tumor Plus as well as its Liquid Trace Hematology ...

DALLAS, Jan. 29, 2024 (GLOBE NEWSWIRE) -- Spectral MD, Inc. (“SMD”), a subsidiary of Spectral AI, Inc. (NASD: MDAI; MDAIW) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company ...

DALLAS, Oct. 19, 2023 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI; MDAIW) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster ...

Genomic Testing Cooperative Receives UKCA Mark for its Portfolio of Hematology, Solid Tumors and Liquid Biopsy Profiles covering DNA and RNA Genomic Testing Cooperative (GTC) today announced it ...