Industry News
The latest medical device regulatory news, clinical trials, and market insights
Swissmedic Updates Signal Management Guidance in PSUR Reporting
Swissmedic has released an update to its guidance document regarding the Authorisation PSUR Signal Management TAM process, effective November 1,…
Cardinal Health Stock Performance and Corporate Profile Update
Cardinal Health, Inc. (NYSE: CAH) has posted a slight gain in its latest trading session, reflecting modest investor optimism. With…
Urgent Recall Alert: Baxter Healthcare’s Hartmann’s Solution Packaging Mix-up
Baxter Healthcare Limited has issued a Class 2 medicines recall after identifying a packaging error involving their Compound Sodium Lactate…
October 2025 MHRA Safety Bulletin: Critical Updates for Medicines and Medical Devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has released its October 2025 safety update, detailing the latest insights and…
Clinical Teams: Significant Updates on Medical Device Field Safety Notices (20–24 October 2025)
Field Safety Notices (FSNs) issued between 20 and 24 October 2025 have recently been compiled for review by clinical, quality,…
FDA Issues Warning on Elevated Risk of Device Failure for Hintermann Series H3 Total Ankle Replacement
The U.S. Food and Drug Administration (FDA) has released an updated safety communication regarding the Hintermann Series H3 Total Ankle…
Artivion Inc. Stock Sees Modest Gain as Market Position Strengthens
Meta description: Artivion Inc. shares gain 0.55% on NYSE amid strong market positioning in the medical devices sector, reflecting steady…
Swissmedic Grants Initial Authorisation for Filsuvez®: A Key Milestone in Advanced Therapies
Swissmedic, the Swiss agency for therapeutic products, has announced the first authorisation of Filsuvez®, marking a pivotal event in the…
Swissmedic Announces New Role for Laboratory IT Systems Specialist in OMCL
Swissmedic, Switzerland’s surveillance authority for medicines and medical devices, has disclosed an exciting new opportunity in its Laboratory Department, particularly…
Swissmedic Authorises New Therapeutic Use for Trecondi®
Swissmedic has announced an update regarding the medication Trecondi®. On October 31, 2025, the regulatory body extended the drug’s therapeutic…
Swissmedic Grants First Authorisation for SWAN-PSMA-1007®: Key Regulatory Insights
On October 31, 2025, Swissmedic announced the first authorisation of SWAN-PSMA-1007®, marking a significant regulatory milestone. This development is relevant…
Swissmedic Updates Position Paper on Decentralised Clinical Trials: Key Changes Explained
On October 31, 2025, Swissmedic and swissethics announced an update to their position paper on decentralised clinical trials (DCTs) for…