European Commission Publishes Third Version of Living Guidelines on the Responsible Use of Generative AI in Research
The European Commission has released Version 3 of its Living Guidelines on the Responsible Use of Generative AI in Research. Learn what the new recommendations mean for medical device manufacturers, clinical evaluation, data protection and research activities.
FDA launches consultation on AI use in early-phase clinical trials
FDA opens consultation on a pilot program to assess artificial intelligence in early-phase clinical trials, focusing on efficiency, safety, and decision-making.
MHRA Updates Guidance on Clinical Investigations and Introduces 2026–2027 Fee Waiver Pilot
MHRA updates its clinical investigations guidance and introduces a 2026–2027 fee waiver pilot for SMEs. Key requirements for medical device manufacturers explained.
FDA launches READI-Home Innovation Challenge focused on reducing hospital readmissions
The FDA launches the READI-Home Innovation Challenge to support medical devices aimed at reducing hospital readmissions through home-based care solutions.
FDA expands TAP Pilot: increased scope and participation
FDA expands its TAP Pilot with more devices and new areas. Key updates and what medical device manufacturers need to know.
FDA Releases Draft Guidance on Bayesian Methodology in Clinical Trials – What It Means for Innovative Study Designs
FDA releases draft guidance on Bayesian methods in clinical trials. Learn how device manufacturers can benefit from this innovative approach.