Approval for Xeltis’s aXess device was based on pivotal trial data that demonstrated 79% secondary patency and a patency ...
NORTHRIDGE, Calif., March 10, 2026 /PRNewswire/ -- MiniMed Group, Inc. (MiniMed), a global leader in full stack insulin delivery, today announced CE (Conformité Européenne) Mark for use of the ...
SQ Innovation, developer of Lasix® ONYU, today announced two important regulatory milestones in its international expansion strategy: the receipt of a CE marking certificate for the Lasix ONYU device, ...
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First-of-its-kind, rotation-free single-shot PFA catheter supported by strong safety and efficacy data adds to the groundbreaking Affera family of technologies in Europe Successful completion of first ...
OrthAlign, Inc., which specializes in handheld orthopedic enabling technology, said it has received CE Mark under the EU MDR ...
VAUGHAN, Ontario--(BUSINESS WIRE)-- Bausch + Lomb Corporation (BLCO:CA), a leading global eye health company dedicated to helping people see better to live better, today announced CE Mark approval for ...
Stereotaxis announced that it has received European CE Mark approval for its MAGiC™ ablation catheter, marking a significant step in advancing robotic technology in electrophysiology. Designed for ...
OrthAlign, Inc., the leader in handheld orthopedic enabling technology, today announced it has received CE Mark under the EU MDR for its portfolio of navigation solutions, enabling commercialization ...
Indication covers newborn infants with hypoxic respiratory failure and peri- and post-operative pulmonary hypertension to improve right ventricular function in conjunction with heart surgery 1) the ...
The Stealth AXiS platform supports customisable adoption based on each hospital’s needs.
Europe is moving towards a more coherent framework for fibre-reinforced polymer (FRP) reinforcement in concrete structures. The European Rebar Council’s (ERC) formal endorsement of CE marking via ...