Medical Device Network on MSN
BD gains FDA clearance and CE mark for bacterial panels on COR System
The panels employ PCR techniques to test for numerous gastrointestinal bacterial pathogens using one stool swab.
First-and-only test of its kind approved under new European Union regulations expands access to personalized cancer care for patients across the EU This in vitro diagnostic (IVD) assay, which has been ...
MARCY L’ETOILE, France--(BUSINESS WIRE)--Regulatory News: Today marks World Tuberculosis (TB) Day and bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, announces the CE ...
REHOVOT, Israel--(BUSINESS WIRE)--Clear-Cut Medical announced the CE Marking of its ClearSight™ MRI system for the examination of breast tissue. The ClearSight™ system is a revolutionary compact ...
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, ...
Maccaferri has been awarded European Technical Approval (ETA) for its RB 1500 (ETA n.12/0396) and RMC 050 ICAT/2 (ETA (n.12/0455) ) rockfall barriers, following stringent testing in accordance with ...
Roche, in collaboration with KlinRisk, Inc, has received CE-mark for the first AI-based risk stratification tool for assessment of progressive decline in kidney function. This tool will be launched as ...
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