The UK has decided to continue recognising the CE mark, however, both sides need to agree on a common way to describe ...
Johnson & Johnson MedTech (NYSE: JNJ) announced that it received CE mark approval for its dual-energy ThermoCool SmartTouch ...
Aiosyn, a pioneering innovator in AI-powered pathology software for cancer and kidney disease, has announced that its ...
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Roche secures CE mark for ovarian cancer detection testRoche has secured CE mark approval for its immunohistochemistry (IHC) companion diagnostic test, VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, for the identification of epithelial ovarian cancer (EOC ...
Under the EU MDR, manufacturers must prepare and submit a comprehensive Technical Documentation File for devices that require CE marking. The Clinical Evaluation Report (CER) is a crucial component of ...
The Medtronic Harmony transcatheter pulmonary valve system provides a minimally invasive alternative for congenital heart ...
Medtronic plc received CE mark approval for its Harmony transcatheter pulmonary valve system to treat congenital heart disease patients with native or surgically repaired right ventricular outflow ...
The CE mark (quality standard) for the barrier systems has also been awarded based on subsequent quality checking of manufacturing, supply and assembly systems. The main strength of both of these ...
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