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 ...

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 ...

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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 ...

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 ...

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 ...

Approvals mark a major milestone and bring the most advanced image quality to date to Swoop® system users in European markets GUILFORD, Conn.--(BUSINESS WIRE)--Hyperfine, Inc. (Nasdaq: HYPR), the ...

Regulations ensure that biomedical equipment meets quality and safety standards, even though navigating compliance can be complex.