European Commission Finalizes Artificial Intelligence A…
The European Commission has officially published the finalized text of the Artificial Intelligence Act (AIA), marking a significant mileston…
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FDA Qualifies Apple Watch AFib History Feature as a New…
On May 1, 2024, the FDA made a significant announcement by qualifying the Apple Watch AFib History Feature as a biomarker test device throug…
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ANVISA Published Regulation For Medical Devices
ANVISA issued Resolution 837/2023 on December 15, outlining updated procedures for clinical investigations supporting higher-risk Medical De…
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RegASK Secures Venture Capital Funding in a Seed Round …
Conducting business globally is an essential piece to many business strategies. However, we often see clients fail to realize the depth of p…
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