Sentante now intends to establish partnerships with hospitals and healthcare providers across Europe to integrate its ...

The Lithuania-based robotic surgery company is advancing a remote stroke system that was accepted into the FDA’s total ...

This article will examine market access outside the EU/EEA based on reliance and recognition. For countries outside the European Union (EU) and European Economic Area (EEA), regulatory reliance and ...

With the ever-increasing stringency, time, and expense associated with FDA approval for medical devices, debate is sharpening in the medical devices industry over whether it is actually better ...

Only a month after Getinge announced the suspension of the CE marks allowing it to sell its heart-lung support and permanent life support systems in Europe, the Swedish devicemaker has temporarily ...

As previously announced, the UK government has enacted legislation to continue the recognition of the CE marking indefinitely for a range of products falling within the scope of 21 regulations, ...

GI Dynamics has lost the right to sell its Type 2 diabetes and obesity device in the European Union. SGS, the notified body for EndoBarrier, pulled the CE Certificate of Conformity over the weekend in ...

Since the European Union’s main aims include consumer protection and ensuring product safety, you might be forgiven for thinking that the EU’s rules in those areas would be clear and straightforward.

Developed, tested, and selected from more than 200 formulations Unique long-chain chemistry formulated and optimized for 3D printing Pioneers a same-day digital denture solution with three times the ...