Industry News
The latest medical device regulatory news, clinical trials, and market insights
CAYA Cancer Study: New Retrospective Insights for Young Cancer Patients
On November 24, 2025, a new retrospective cohort study focusing on childhood, adolescent, and young adult cancers (CAYA) was announced.…
Exploring the Impact of Physical and Cognitive Training on Elderly Quality of Life: A Clinical Perspective
A new clinical trial led by the University Hospital of Ferrara, in collaboration with Università degli Studi di Ferrara, focuses…
Function Health Secures $298M Series B Funding At $2.5B Valuation
Meta description: Function Health raised $298 million in its Series B round, reaching a $2.5 billion valuation and attracting top-tier…
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 Laryngoscope, manufactured by Intersurgical…
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 kits containing the Flexicare…
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®, a therapeutic option designed…
Swissmedic Expands Use of Breyanzi®: Updated Authorization Details
On November 22, 2025, Swissmedic announced the extension of the therapeutic indication for Breyanzi® (lisocabtagene maraleucel). This change has important…
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 an important milestone in…
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, 2025, this authorisation introduces…
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 extended the therapeutic…
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). This announcement highlights crucial…
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 enhance clarity for manufacturers,…