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CE mark: Page 2
BD nabs CE Mark for respiratory viral panel
The panel, a molecular diagnostic combination test for SARS-CoV-2, influenza A + B, and respiratory syncytial virus (RSV), uses a nasal swab or nasopharyngeal swab sample.
June 30, 2022
Pictor receives CE Mark for COVID-19 test
The PictArray SARS-CoV-2 assay is the first test of its kind, according to the company. The test enables personalized COVID-19 assessments by detecting if a patient has antibodies from a previous infection of SARS-CoV-2 (from spike protein and nucleocapsid protein antibodies) or from vaccination alone (SP antibodies only).
June 22, 2022
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
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
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