Certaldo, Italy, October 11, 2024 – Endostart, a pioneering medical device company specializing in gastrointestinal endoscopy solutions, today announces that it has obtained CE marking for the ...

“The EU applies the CE Marking process primarily to ensure safety, as well as a reinforced manufacturer obligation with respect to device claims. The FDA does this too, but has the additional ...

In its letter to the European Commission, the European Organisation of Technical Assessment (EOTA) and stakeholders in the construction sector, the ERC advocates the adoption of CE marking through the ...

BBS Bioactive Bone Substitutes Oyj ‘s Notified body BSI has become to the conclusion that the provided clinical data is insufficient as required by the new MDR and as a result they will proceed ...

PARIS--(BUSINESS WIRE)--Regulatory News: CARMAT (FR0010907956, ALCAR), designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for ...

LITTLETON, Mass.--(BUSINESS WIRE)--Mevion Medical Systems, the global leader in compact proton therapy, today announced that the MEVION S250-FIT Proton Therapy System has successfully completed the ...