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 ...

and evidence synthesis ensuring a smooth CE marking process and long term market sustainability. What is Technical Documentation and the Role of Consultants in IVDR Compliance Technical ...

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 ...

Partnering with experienced regulatory consultants like I3CGLOBAL provides valuable insights, streamlining compliance and enhancing market readiness. This proactive strategy ensures CE marking and ...

Los Angeles, CA, April 09, 2025 (GLOBE NEWSWIRE) -- ANEUVO, a pioneer in non-invasive therapy development, proudly announces two pivotal milestones that set the stage for global expansion ...

CONCORD, Calif., March 05, 2025--(BUSINESS WIRE)--Cerus Corporation (Nasdaq: CERS) announced today the CE mark approval of its next-generation LED-based illumination device, or the INT200 ...

Norlase, a leading global ophthalmic laser manufacturer, announced the immediate commercial launch and FDA 510(k) clearance and CE Mark for Norlase LYNX ... Daniel Diaz, Retina Consultants of Miami, ...

Beam Global announced that its products, including EV ARC™, BeamBike™, BeamWell™, and BeamPatrol™, have received the CE mark, which signifies compliance with European Union health ...

The CE marking allows Nevro to market HFX iQ in all countries that ... anesthesia and pain management consultant at Leeds Teaching Hospital NHS Trust. “By leveraging AI technology and data-driven ...