News

St. Jude Medical Inc. ( STJ ) has received CE Mark approval for its EnligHTN renal denervation system for treating patients ailing from hypertension..
The CE mark allows manufacturers to sell their products throughout the EEA without needing to adapt them to different national regulations, fostering a single market for goods. It signifies that a ...
In 2006, EU legislation implemented the CE mark as the mark of an accurate measure on pint glasses. This meant all glasses had to bear the CE mark, but the EU rules did not ban the crown symbol, and ...
The EU CE mark for the companies’ AI-powered AiMIFY software for enhancing contrast MRI scans follows its FDA clearance in 2024.
What Rishi Sunak’s climbdown over the CE safety mark means Brexiteers fear backtracking on symbolic standard sets a precedent for maintaining EU rules ...
Beyond Air (XAIR) announced European CE mark approval of the LungFit PH system. This CE mark approval allows Beyond Air to market LungFit PH in the European Union and all other countries that ...
“This approval clears the path for the commercial launch of CGuard ® Prime EPS across our current CE marked served markets, taking a pivotal step forward in our growth as a commercial-stage ...
With the CE Mark, Zimmer Biomet will make the RibFix Advantage Fixation System available in the European Economic Area (EEA) and other markets that recognize the CE Mark.
The CE mark had been due to be replaced by the UKCA symbol – denoting that products conformed to the safety, health, and environmental protection requirements of British law.
Britain on Tuesday said it would retain the European 'CE' safety mark for products indefinitely rather than scrap it following the country's departure from the European Union, in a move welcomed ...
Because health care providers that choose to purchase devices without a CE mark will be held accountable, the IGJ requires them to record their considerations and decisions in this regard.
The UK government has decided to recognise the EU's product safety symbol indefinitely, in a post-Brexit climbdown.