The platform uses impedance flow cytometry to measure the electrical properties of bacteria that have been plated from a positive blood culture sample.
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Our recent briefing note (available here) explained that CE product safety marking, which is required to sell certain types of goods in the European Union, was being replaced by the UKCA mark in Great ...
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 ...
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 ...
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