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The first DF-4 implants were approved in the US in April 2009, followed shortly thereafter by CE-mark approval in Europe.
The Acorn CorCap™ CSD received CE mark approval in Europe in 2001 and has been available to a small number of centers in a Limited Market Release Surveillance Study LMRSSS).
Despite this, the Nobels are typical of the many prizes established within science that reward success, mark approval, consolidate a sense of community and, often, create public interest.
For example, in Europe, the ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System met the requirements of the Directives specified by the European Union for all medical devices and received CE mark approval.
In the EU, the PULSANTE system is available for the treatment of episodic and chronic cluster headache since obtaining CE mark approval in 2012.
Boston Scientifics PROMUSElement Everolimus-Eluting Coronary Stent System was given CE Mark approval for use in patients suffering from diabetes and for use in those patients experiencing a heart attack.
These systems have US Food and Drug Administration and CE mark approval and have been marketed since July 2001.
After extensive testing in our study, the catheter successfully underwent the procedure for European Mark approval.
However, the GeneXpert kit has not yet received CE mark approval for this purpose.
Then, in 2006, the Melody valve received CE Mark approval in Europe and Health Canada approval, making it the first commercially available transcatheter valve in the world.
All patients were treated with a novel percutaneous vertebral augmentation device (Kiva® VCF Treatment System, Benvenue Medical, Santa Clara, CA, USA), which received CE Mark approval in December 2008.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com