Article 4 “Free Movement of Devices Intended for Special Purposes,” Article 17 of the MDD “CE Marking,” Article 18 “Wrongly Affixed CE Marking,” and Annex XII “CE Marking of Conformity” provide ...
Profusa received a positive decision from GMED on ISO 13485 certification, expected in early October, while additional European MDR conformity assessment work remains before the Lumee Oxygen Platform ...
With the ever-increasing stringency, time, and expense associated with FDA approval for medical devices, debate is sharpening in the medical devices industry over whether it is actually better ...
Gaining authorization for transvaginal gynecologic procedures expands the list of indications for da Vinci SP in Europe.
As previously announced, the UK government has enacted legislation to continue the recognition of the CE marking indefinitely for a range of products falling within the scope of 21 regulations, ...
TAMPERE, Finland, Feb. 14, 2025 /PRNewswire/ -- Bioretec Ltd., a pioneer in absorbable orthopedic implants, has achieved a pivotal milestone with the successful completion of its CE mark approval ...
Only a month after Getinge announced the suspension of the CE marks allowing it to sell its heart-lung support and permanent life support systems in Europe, the Swedish devicemaker has temporarily ...
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--TransEnterix, Inc. (NYSE American:TRXC), a medical device company that is digitizing the interface between the surgeon and the patient to improve ...
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BLCO gains European CE mark for next-gen SeeLyra femtosecond laser
Bausch + Lomb BLCO recently announced that its next-generation SeeLyra femtosecond laser has received European CE Mark ...
A summary of the CE Marking process which is required for certain products to be lawfully sold within the Single Market. What is CE Marking? The CE Mark is a self certified mark that is put on certain ...
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