Between 10 and 14 November 2025, significant Field Safety Notices (FSNs) were announced, carrying potential implications…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
FDA Issues Critical Recall Alert for Intersurgical i-View Video Laryngoscopes
On November 22, 2025, the FDA released details regarding a significant recall of the i-View Video…
Critical Update: Revised Instructions for Flexicare BritePro Solo Devices in Medline Kits
Medline Industries, LP has issued an urgent revision to the use instructions for Medline medical convenience…
Swissmedic Confirms First Authorisation for Lutathera®: Key Regulatory Update
On November 22, 2025, Swissmedic published an important regulatory update announcing the first authorisation of Lutathera®,…
Swissmedic Expands Use of Breyanzi®: Updated Authorization Details
On November 22, 2025, Swissmedic announced the extension of the therapeutic indication for Breyanzi® (lisocabtagene maraleucel).…
Swissmedic Authorizes 18F-PSMA-1007 ZRP®: Key Insights for Regulatory and Clinical Teams
On November 22, 2025, Swissmedic officially granted the first authorization of 18F-PSMA-1007 ZRP®. This approval represents…
Swissmedic Grants First Authorisation of Radelumin®: A Regulatory Milestone
Swissmedic has announced the first authorisation of Radelumin®, marking a significant regulatory achievement. Effective November 22,…
Swissmedic Update: Expanded Indication Approval for NexoBrid®
Swissmedic, Switzerland’s medical regulatory authority, has announced an important update regarding NexoBrid®. On November 22, 2025,…
Swissmedic Issues DHPC for DIBASE® 10’000 to Address Handling Errors
On November 22, 2025, Swissmedic released a Direct Healthcare Professional Communication (DHPC) concerning DIBASE® 10’000 (cholecalciferolum).…
Health Canada Releases Updated Guidance on Medical Device License Applications
Health Canada has published updated guidelines for managing medical device license applications. These regulations aim to…