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Results For "CE-Mark"

82 News Found

Roche to launch SARS-CoV-2 and flu A/B Rapid Antigen Test in countries accepting the CE mark
Medical Device | December 06, 2021

Roche to launch SARS-CoV-2 and flu A/B Rapid Antigen Test in countries accepting the CE mark

The combination rapid antigen test quickly differentiates between SARS-CoV-2 and influenza viruses A and B infections, with results ready in less than 30 minutes, allowing informed decisions on patient and pandemic management decisions


Medtronic’s robotic-assisted surgery system receives European CE mark
Medical Device | October 12, 2021

Medtronic’s robotic-assisted surgery system receives European CE mark

In Western Europe, about 2% of procedures are done robotically while the majority, approximately 65%, are open surgery


Wyss Center receives CE mark for Epios Cloud software
Digitisation | September 30, 2021

Wyss Center receives CE mark for Epios Cloud software

The cloud-based platform enables long-term brain monitoring towards personalized treatment


Roche launches three respiratory test panels on Cobas 6800/8800 Systems in CE markets
Medical Device | September 23, 2021

Roche launches three respiratory test panels on Cobas 6800/8800 Systems in CE markets

Three new molecular diagnostic test panels for influenza and other common respiratory illnesses can be run together or alone using one patient sample


Zymo Research receives CE Mark for new Covid-19 SafeCollect kits
Drug Approval | September 01, 2021

Zymo Research receives CE Mark for new Covid-19 SafeCollect kits

Self-collection devices designed for ease of use and safety


Merck breaks ground on $3 billion center of excellence for pharma manufacturing in Virginia
News | October 22, 2025

Merck breaks ground on $3 billion center of excellence for pharma manufacturing in Virginia

The expansion underscores Merck’s commitment to invest more than $70 billion in U.S. research, development and capital projects


Roche’s Elecsys pTau181 becomes first FDA-cleared blood test to rule out Alzheimer’s pathology in primary care
R&D | October 14, 2025

Roche’s Elecsys pTau181 becomes first FDA-cleared blood test to rule out Alzheimer’s pathology in primary care

New test expands access to early Alzheimer’s assessment, streamlining diagnostic pathways and improving referral efficiency


Vasa Therapeutics secures FDA IND clearance to advance VS-041 into clinical trial for HFpEF
Drug Approval | October 14, 2025

Vasa Therapeutics secures FDA IND clearance to advance VS-041 into clinical trial for HFpEF

IND clearance enables initiation of Phase 1c clinical trial in HFpEF patients with elevated endotrophin levels


Roche’s AI-based kidney disease algorithm gains European certification
Digitisation | October 06, 2025

Roche’s AI-based kidney disease algorithm gains European certification

The new algorithm will be introduced as part of Roche’s CKD Algorithm Panelon thenavify Algorithm Suite