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CE mark: Page 2
Nonagen Bioscience secures CE Mark for bladder cancer test
The urine test detects 10 biomarkers associated with bladder cancer, the company said.
June 16, 2022
Ibex Medical Analytics gets CE Mark for AI-based gastric test
The test was developed by a team of pathologists, data scientists, and software engineers who implemented deep learning technologies and trained algorithms on more than one million image samples, which had been scanned from biopsy slides digitized using digital pathology.
June 14, 2022
Thermo Fisher Scientific obtains CE Mark for NGS, Dx workflows
According to Thermo Fisher, the Ion Torrent Reporter Software Aneuploidy Dx Workflows provide qualitative determination of aneuploidies, including the trisomy status of chromosome 21, in genomic DNA derived from human cells using next-generation sequencing (NGS).
June 14, 2022
Innova Medical receives CE Mark for SARS-CoV-2 antigen test
Innova CEO Robert Kasprzak said in a statement that the firm has delivered more than 1.5 billion lateral flow tests to customers worldwide since the outbreak of the COVID-19 pandemic.
June 8, 2022
Proscia nabs CE Mark under IVDR for digital pathology platform
Concentriq Dx is designed to support laboratories in realizing pathology's artificial intelligence (AI)-enabled future, Proscia said, adding that its platform enables lab networks to unify pathology operations and eliminate geographic silos.
June 7, 2022
CorDX obtains CE Mark for test for COVID-19, flu A/B, RSV
"As COVID-19 infection prevention measures relax globally, COVID and other viral infections are projected to rise," CorDx founder and CEO Jeff Yufeng Li said in a statement.
June 2, 2022
Researchers find hidden bacteria that pose antimicrobial resistance risk to hospital patients
Quest Diagnostics Q4 revenues down 15% on COVID testing but base business grew
SD Biosensor, SJL Partners complete acquisition of Meridian Bioscience
OIG report outlines challenges with CDC-supported COVID-19 vaccination programs
Roche reports flat diagnostics revenue growth for 2022
Duke University developing blood test to detect osteoarthritis progression in the knee
LumiraDx diabetes test receives CE Mark
The LumiraDx HbA1c test is used with the LumiraDx Platform for monitoring individuals with diabetes and provides results in less than seven minutes from sample application. The test is further used as an aid in screening and identifying patients who may be at risk for developing diabetes at the point of care, the company said.
June 1, 2022
VolitionRx gets CE Mark for NETs test
The CE Mark enables the clinical use of the blood test, which can also predict disease severity and monitor progression and response to treatment, in more than 27 countries across Europe.
June 1, 2022
Invenio’s Nio Glioma Reveal receives CE Mark
The module is available for research use only in the U.S. and not for use in diagnostic procedures. It is designed to detect the infiltration of cancer in patients who are undergoing primary treatment of a diffuse glioma.
May 26, 2022
Hologic gets CE Mark for fusion transplant pathogen tests
Panther Fusion EBV Quant Assay and Panther Fusion BKV Quant Assay quantify the viral load of the respective viruses with the aim to aid in the diagnosis and management of solid organ transplant patients and hematopoietic stem cell transplant patients.
May 24, 2022
Indica gets CE-IVD Mark for prostate cancer screening tool
The algorithm helps pathologists identify and grade prostate cancer from core needle biopsy samples. It was developed by researchers at the University of Cologne in Germany and was trained with more than 870,000 digital scans of prostate cancer subtypes as well as healthy tissue.
May 22, 2022
LumiraDx COVID antigen test receives CE Mark
The company said the test allows users to complete up to 80 tests per eight-hour day on a single LumiraDx instrument and matches the LumiraDx SARS-CoV-2 Ag 12-minute test in terms of performance.
May 19, 2022
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