The recent update to ISO 15223-1, formalized through Amendment 1:2025, ushers in a critical shift for medical device labeling ...

Optune Lua received a CE Mark for metastatic non–small cell lung cancer with immune checkpoint inhibitors or docetaxel.

“Securing CE Mark approval for PerQseal Elite marks ... We’re proud to bring this innovative technology to clinicians across Europe.” The PerQseal Elite vascular closure system is placed ...

HF specialists in Europe now have an approved device-based treatment for diastolic HF patients that has been shown to improve quality of life and to reduce their need for HF-related ...