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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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 ...
CMR Surgical received the approval for abdominal surgery for its Versius platform in patients under age 18 in Europe, while ...
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 ...
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 ...
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 ...
SAN DIEGO--(BUSINESS WIRE)--ClearNote Health, a company focused on improving early detection for some of the deadliest cancers, today announced that it has received UK Conformity Assessed (UKCA) ...
Small, modular design of the Versius system supports use in robotic-assisted paediatric surgery Cambridge, UK – 8 January 2026, CMR Surgical (‘CMR’ or ‘the Company’), the global surgical robotics ...
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