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 ...

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 ...

Pulsecath BV secured a CE mark under the Medical Device Regulation (MDR) for its Ivac 2L system, a percutaneous mechanical circulatory support device, four years after it began the process. “It took ...

SeeTreat announced today that its offline adaptive radiotherapy software, ART.1, has received CE Mark certification under the European Union Medical Device Regulation and is now available for clinical ...

Modular Medical (MODD) is continuing to progress toward CE Mark certification under the European Union Medical Device Regulation. As part of this ...

COPENHAGEN, Denmark, September 09, 2025--(BUSINESS WIRE)--Neurescue ApS today announced CE Mark approval for the NEURESCUE ® device, the first and only medical device approved to treat non-shockable ...

KANSAS CITY, Mo., March 1, 2011 (GLOBE NEWSWIRE) -- Cerner Corporation today announced that the CareAware iBus has received CE Marking certification from BSI on the basis of examination under Council ...

VALENCIA, Calif., Sept. 14, 2025 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) (“AVITA Medical”, or the “Company”), a leading therapeutic acute wound care company, today announced ...

Shares of Avita Medical rose after the company said its Recell Go skin healing device received the CE mark, which labels a product as meeting European Union standards. The designation allows the ...

SALT LAKE CITY--(BUSINESS WIRE)--Spectrum Solutions, LLC today announced receiving CE Mark approval for the sale and distribution of its groundbreaking SDNA saliva collection device for IVD molecular ...