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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Medical Devices
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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Medical Devices
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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Medical Devices
Rice-Sized Device Tests Brain Tumor’s Drug Responses …
An NIH-funded team has developed a miniature device with the potential to predict the therapeutic option that will work best for a given tum…
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Medical Devices
Brazil CONEP/CNS Publish Guidelines for Ethical Review …
Brazilian National Commission on Ethics in Research – CONEP/CNS has published on its website a Circular Notice, which provides guidance on…
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Medical Devices
US FDA Issues Revised Guidance on Qualification of Medi…
This final guidance supersedes Qualification of Medical Devices Development Tools: Guidance for Industry, Tool Developers, and Food and Drug…
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Medical Devices
Health Canada Implements ICH Guideline on Nonclinical B…
Health Canada has announced the implementation of guideline S12 on nonclinical biodistribution considerations for gene therapy. The guide…
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Medical Devices
Clinical trials of Medical Devices – Updates Rega…
There have been so many changes in the clinical trial framework in Italy including four new decrees concerning clinical trials on medical de…
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Medical Devices
Indonesia Published News about Filling in Medical Devic…
Ministry of Health (MOH) Indonesia published news about Filling in Medical Devices Dictionary Data. Based on Government Regulation No. 46…
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Medical Devices
Taiwan Published Guidelines for Decentralized Measures …
Taiwan Food and Drug Administration published Guidelines for Decentralized Measures for the Implementation of Drug Clinical Trials. Below is…
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Medical Devices