FDA Launches “Elsa”: Agency-Wide Generative…
On June 2, 2025, the U.S. Food and Drug Administration (FDA) officially launched Elsa, a generative artificial intelligence (AI) tool develo…
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ANVISA Publishes Preliminary Manual for Brazil’s UDI …
ANVISA Publishes Preliminary Manual for Brazil’s Unique Device Identification (UDI) Database May 28, 2025 – The Brazilian National Healt…
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ANSM (France) Clarifies CE Mark Exemption Process for M…
On January 27, 2025, the National Security Agency of Medicines and Health Products (ANSM) in France issued a key update regarding the proces…
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FDA (USA) Issues Final Guidance on Predetermined Change…
On December 4, 2024, the U.S. Food and Drug Administration (FDA) issued its final guidance, “Marketing Submission Recommendations for …
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China Approves Carbon Ion Therapy, Marking Cancer Treat…
On September 29, 2024, the National Medical Products Administration (NMPA) approved the registration of the Carbon Ion Therapy System. This …
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Ministry of Food and Drug Safety Revises Guidelines for…
The Ministry of Food and Drug Safety revised the “Innovative Medical Devices Priority Review Guidelines (Guide for Applicants)” …
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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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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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