First-and-only test of its kind approved under new European Union regulations expands access to personalized cancer care for patients across the EU This in vitro diagnostic (IVD) assay, which has been ...

The UKCA mark was introduced in the Great British (GB) market to replace the European CE mark following Brexit. Products which require a CE mark in the EU must comply with the UKCA marking regime if ...

The CE mark was granted based on data from retrospective studies in real-world early cognitive decline population.

Swiss drugmaker Roche has received the CE mark - a European regulatory clearance ​allowing sale in the ‌region - for its ...

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 ...

On 28 April 2023, the UK’s medical devices regulator, the Medicines & Healthcare products Regulatory Agency (MHRA), announced its intention to extend the acceptance of CE marked medical devices in ...

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is requesting feedback on a proposal to allow EU CE-marked medical devices sold in Great Britain to be recognized and sold ...

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 ...

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 ...

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PRINCETON, N.J. and PARIS., STENTYS, a medical technology company commercializing the world's first and only Self-Apposing® coronary stent, today announced that the Company’s Drug-Eluting stent ...

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