CE mark: Page 3

Indica gets CE-IVD Mark for prostate cancer screening tool
By LabPulse.com staff writers
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
2022 05 23 20 07 1373 2022 05 23 Indica Labs Halo Prostate Ai 400
LumiraDx COVID antigen test receives CE Mark
By LabPulse.com staff writers
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
2021 01 11 17 03 4617 Covid Diagnostic Test Kit 400
FDA clears Hologic's assay for human cytomegalovirus
By LabPulse.com staff writers
It is Hologic's first test to be available in the U.S. for identifying post-transplant pathogens using the company's automated Panther system. Aptima CMV Quant also has the CE Mark for diagnostic use and viral load testing in Europe, Hologic said.
May 11, 2022
2022 04 29 18 14 4601 Hologic Rsna 2019 400
Agilent secures CE-IVD Mark for cervical cancer test
By LabPulse.com staff writers
PD-L1 is an antibody expressed by cervical cancer tumors and is a key biomarker for predicting response to anti-PD-L1 therapies like Keytruda, according to Agilent. The company's PD-L1 IHC 22C3 pharmDx companion diagnostic identifies cervical cancer patients with a PD-L1 combined positive score of one or more, which indicates that they could benefit from treatment with Keytruda, the company said.
May 10, 2022
2019 11 07 23 47 6944 Squamous Epithelial Cells Cervical 400
Innova partners with Attomarker on COVID immunity test
By LabPulse.com staff writers
Through the partnership, Innova has made a minority investment in Attomarker and will become an official distributor of the latter's products.
May 5, 2022
2021 01 11 17 03 4617 Covid Diagnostic Test Kit 400
SeekIn receives CE Mark for karyotyping kit
By LabPulse.com staff writers
Designed to show copy number alteration patterns in leukemia patients based on shallow whole-genome sequencing, the test can help hematologists make diagnoses and prognostic decisions based on European Leukemia Net, Revised International Prognostic Scoring System, or Revised International Staging System guidelines, according to the vendor.
April 6, 2022
2019 05 21 23 51 7032 Blood Cell Clot 400
C2i Genomics launches MRD test in Europe
By LabPulse.com staff writers
The test is the first software-as-a-medical-device MRD test and will be available in countries accepting the CE Mark, according to the company. Recently, it received CE-IVD marking in the European Union, U.K., and Switzerland.
April 5, 2022
2021 01 12 23 44 3780 Blood Test Samples Lab 400
Optellum's Virtual Nodule Clinic receives CE Mark
By LabPulse.com staff writers
Virtual Nodule Clinic is an AI-powered clinical decision support software tool designed to help clinicians identify and track at-risk patients who present suspicious lung nodules that may or may not be cancerous.
March 30, 2022
2021 08 18 23 12 2135 Computer Ai Artificial Illustration 400
Thermo Fisher launches new NGS platform
By LabPulse.com staff writers
Designed for use in clinical laboratories, the system enables users to perform both diagnostic testing and clinical research on a single instrument, according to the vendor. Results are delivered in as little as one day, Thermo Fisher Scientific said. The system has received the CE-IVD mark.
March 29, 2022
2022 03 30 21 50 0563 2022 03 30 Thermojpg 400
Sense wins CE Mark for Veros COVID-19 test
By LabPulse.com staff writers
Designed to provide results in 15 minutes at a performance comparable to polymerase chain reaction diagnostic technology, Veros COVID-19 is suitable for use in environments such as hospital emergency departments, pharmacies, care homes, and urgent care, according to Sense. In a multicenter trial, the IVD test yielded an accuracy rate of 97.9%, Sense said.
March 7, 2022
2022 03 08 19 48 7131 Ce Mark Business 400
Luminex secures CE Mark for NxTag pathogen panel
By LabPulse.com staff writers
NxTag GPP is designed to detect nucleic acids from 16 clinically relevant bacterial, viral, and parasitic pathogens, according to Luminex. The test provides same-day results and can run as many as 96 samples at a time, the company said. What's more, the test's targets can also be customized by users.
March 7, 2022
2022 03 08 19 56 8772 Clearance Stamp 400
Diadem wins CE-IVD Mark for Alzheimer's prognostic blood test
By LabPulse.com staff writers
The prognostic blood test can predict likely progression to Alzheimer's disease up to six years in advance of symptoms, according to the company. AlzoSure previously received breakthrough device designation by the U.S. Food and Drug Administration (FDA) in January.
February 28, 2022
2022 03 02 00 55 3488 Woman Dementia Alzheimer 400
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