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Results For "CE-Mark"

90 News Found

Sense receives CE marking for Veros Covid-19 instrument-free molecular test
Medical Device | March 08, 2022

Sense receives CE marking for Veros Covid-19 instrument-free molecular test

Sense anticipates launching Veros Covid-19 in Europe this quarter, initially in Ireland, Benelux and the Nordic regions


Indica Labs receive CE Mark for its HALO AP
Medical Device | January 10, 2022

Indica Labs receive CE Mark for its HALO AP

The HALO AP platform was developed by Indica Labs to address the specific needs of anatomic pathology labs by supporting a wide range of tissue-based workflows, including primary diagnosis, secondary consults, tumour boards, clinical trials, synoptic reporting, quantitative analytics, and AI


Algorithmic Biologics receives CE mark for Tapestry platform
Startup | December 10, 2021

Algorithmic Biologics receives CE mark for Tapestry platform

The platform’s technology works as a compression algorithm for molecular testing


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


FDA nod to first oral single-dose treatment for gonorrhea
Drug Approval | December 16, 2025

FDA nod to first oral single-dose treatment for gonorrhea

The approval of Nuzolvence (zoliflodacin) follows a collaborative development effort with the Global Antibiotic Research and Development Partnership


Bristol Myers Squibb secures FDA nod for Breyanzi in marginal zone lymphoma
Drug Approval | December 06, 2025

Bristol Myers Squibb secures FDA nod for Breyanzi in marginal zone lymphoma

The one-time CAR T cell infusion now becomes the first and only therapy of its kind cleared for this patient population