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

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

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 ...

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 ...

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 ...

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 ...

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 ...

The Kardia 12L, which uses five electrodes and a single cable to replace bulky 10-lead ECG carts, has received CE Mark. It launches first in France, Germany, Italy, Spain, and the UK, with its AI ...

The Elekta Unity high-field MR-linac is now CE marked. (Courtesy: Elekta) Elekta has announced that its Unity MRI-guided radiotherapy system (MR/RT) system has received the CE mark, clearing the ...

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