The CE Marking approval indicates that a medical device meets the requirements of the European Medical Devices Directive. Until now, Materialise’s personalized devices made use of the custom-made ...
ST. PAUL, Minn.--St. Jude Medical, Inc., a global medical device company, today announced European CE Mark approval of its AMPLATZER™ Amulet™ Left Atrial Appendage Occluder. The Amulet device is used ...
GALWAY, Ireland & OCEANSIDE, Calif.--(BUSINESS WIRE)--Palliare, a leading developer of advanced insufflation technologies, has received EU CE Mark certification under the new EU Medical Devices ...
SAN FRANCISCO, Oct. 23, 2025 /PRNewswire/ -- Alife Health, a health tech company advancing the future of fertility care with artificial intelligence, today announced that Embryo Predict™, its ...
Acutus Medical has received two CE marks this week for heart treatment devices and access tools and has begun their European commercial launch. This includes a green light for a line of minimally ...
Medical Device Network on MSN
Nitinotes gains CE mark for endoscopic gastroplasty suturing platform
Nitinotes Surgical has gained a CE mark for EndoZip, allowing the company to launch the automated suturing platform for endoscopic sleeve gastroplasty (ESG) in Europe.
Cerus Corporation has obtained CE mark approval for its INT200, a light-emitting diode (LED)-based illumination device, for the Intercept Blood System for platelets and plasma. This approval, under ...
CAMBRIDGE, Mass., Aug. 7, 2025 /PRNewswire/ -- SurgiBox, a medical technology company committed to improving access to safe, clean surgery at the point of need, announced today it has received the CE ...
In response to the COVID-19 outbreak, the Dutch Healthcare and Youth Inspectorate grants manufacturers and suppliers of medical devices the temporary opportunity to supply medical devices without a CE ...
Medical Device Network on MSN
Overture Life gains CE mark for automated IVF system
Overture’s DaVitri system aims to make egg thawing and freezing processes during IVF more consistent to improve successful ...
The European breast implant recall raises questions about the effectiveness of the European Union’s CE Mark medical device approval process say critics of the process, according to a MassDevice report ...
Commenting on the clearance, John O’Dea, CEO, said “We believe that this is an important step forward for our company. Certifying EVA15 as a Class 2b device to the new MDR regulation has entailed an ...
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