InspireMD today announced it received CE Mark approval for its CGuard Prime carotid stent system for the prevention of stroke ...

Billboard can exclusively reveal that the Los Angeles singer-songwriter-model is teaming up with with Transparent Arts for his music career and other projects. Mark will release his new single ...

Optune Lua received a CE Mark for treating metastatic NSCLC, used with immune checkpoint inhibitors or docetaxel after progression on a platinum-based regimen. The phase 3 LUNAR trial showed ...

Receipt of EU MDR CE mark may not be a magic potion, but Elixir Medical Corp. is certainly feeling a boost from the regulatory nod for its mechanical Lithix hertz contact intravascular lithotripsy ...

Edwards Lifesciences Corp.’s Sapien M3 secured CE mark for its Sapien M3 mitral valve replacement system for transfemoral treatment of patients with mitral valve disease who are ineligible for surgery ...

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 CE Mark certifies that ExaStim meets the European Union’s stringent health, safety, and environmental protection standards under Medical Devices Regulation (EU) 2017/745. This certification ...

Zimmer Biomet (NYSE:ZBH) announced Tuesday that the EU regulators granted CE Mark certification for the company’s RibFix Advantage Fixation System, designed as a less invasive approach to rib ...

(PRNewsfoto/Zimmer Biomet Holdings, Inc.) "Following the success of RibFix Advantage Fixation System in the United States and other markets, we are excited to introduce it in CE Mark markets and ...

"Following the success of RibFix Advantage Fixation System in the United States and other markets, we are excited to introduce it in CE Mark markets and support our customers with solutions that ...

Cerus Corporation (NASDAQ:CERS) said on Wednesday that the company received CE mark approval for its illumination device, the INT200, to commercialize in the European Union. This device is part of ...