FDA’s LDT rule struck down in Texas court
Published in 2024, the FDA’s ‘Final Rule’ outlined plans to subject lab-developed tests to the same requirements as medical devices.
Medtronic recalls flow-diverting stents
Cleerly CONFIRM2 study finds women with CAD at higher risk of MACE
FDA grants expanded 510(k) clearance for Epitel’s wireless EEG system
Medtronic reports late-breaking data from TAVR system trial for aortic stenosis
FDA authorises Visby Medical’s at-home test for common STIs
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View MoreEU Health Data Space strikes a chord in EU harmonisation plans
EU member states are set to launch the EU Health Data Space Regulation for harmonised data transfer on 26 March.
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Data Insights
View MoreArtificial intelligence: who are the leaders in histology image analysis software for the medical devices industry?
The medical devices industry continues to be a hotbed of patent innovation. Activity is driven by increased need for homecare,...
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‘Great promise’ for AI-assisted clinical decision-making
Apple’s hearing aid software is impressive, but audiologists still matter
AngioInsight to assess AI-powered platform for cardiovascular diagnosis
NHS ups AI push with Cera software rollout for fall prediction