CE mark: Page 4

SeekIn receives CE Mark for cancer detection kit
By LabPulse.com staff writers
The company has an artificial intelligence (AI)-based platform that uses private and public data to identify weak cancer DNA and protein signals in the blood and trace them back to a tissue of origin. SeekIn also has patents on algorithms to reduce background noise and reveal cancer signals in blood.
February 24, 2022
2019 07 15 18 08 8235 Artificial Intelligence Ai Data 400
Ellume, Qiagen win clearance for TB test
By LabPulse.com staff writers
With the approval, QIAreach QFT will now be available to public health programs and institutions in more than 100 countries that qualify for Global Fund and/or UNITAID resources. It will also be available through the Stop TB Partnership's Global Drug Facility, Ellume said.
January 10, 2022
2022 01 11 22 22 7293 Lung Tuberculosis Art 400
Hemanext submits blood cell processing device to FDA
By LabPulse.com staff writers
Hemanext One was designed to process and store eligible RBCs with the goal of limiting oxygen and carbon dioxide exposure, two significant drivers of RBC damage, Hemanext said. The objective is to improve outcomes for patients with blood disorders and those in need of transfusions, the company said.
January 6, 2022
2020 10 19 22 00 1118 Blood Cells 400
Avacta's SARS-CoV-2 test gets CE Mark
By LabPulse.com staff writers
The test, which uses a nasal swab and gives results in 20 minutes, has been developed using Avacta's proprietary Affimer platform to identify individuals with a higher viral load.
December 21, 2021
2021 04 27 22 24 2298 Nasal Swab Test 400
BD Cor system features MX instrument for infectious diseases
By LabPulse.com staff writers
The new instrument and its first test for sexually transmitted infections have received the CE Mark for IVD directive 98/79/EC.
December 16, 2021
2021 12 17 21 37 8846 2021 12 17 Bd Cor 2018 Straight Modules Px Mx 20211217212630
Roche launches test on new Cobas 5800 lab system
By LabPulse.com staff writers
The following Cobas tests can run on the new compact system:
December 14, 2021
2020 04 14 17 10 6379 Test Tubes Rd Lab 400
Eurofins debuts 2 combined tests for COVID/influenza, RSV
By LabPulse.com staff writers
The new multiplex kits have been granted the CE Mark and are designed to detect and differentiate three viral infections in the same PCR run, Eurofins said.
November 30, 2021
2020 04 29 22 14 7161 Lab Blood Dropper V2 400
Hologic receives CE Mark for Genius cervical cancer software
By LabPulse.com staff writers
The new algorithm analyzes ThinPrep Pap images to narrow tens of thousands of cells down to an AI-generated gallery to find lesions and cancer cells. This arms healthcare providers with the critical information they need to guide earlier detection and better treatment decisions for the patients in their care, the company said.
November 3, 2021
2021 11 04 18 10 3690 2021 11 04 Hologic Genius 400
Baxter, BioMerieux receive CE Mark for kidney test
By LabPulse.com staff writers
The companies highlighted the results of a study that showed the test's area under the receiver operating characteristic curve was 0.82, demonstrating its ability to distinguish patients who will likely develop such kidney injuries from those who will not.
October 21, 2021
2019 12 21 00 26 9702 Kidneys 400
Agilent enters digital pathology with Visiopharm deal
By LabPulse.com staff writers
Visiopharm's artificial intelligence-driven precision pathology software products have the CE Mark for in vitro diagnostic devices. The products are designed to improve diagnostic accuracy and workload management for pathologists, according to Agilent.
September 1, 2021
2020 09 08 18 51 2374 Business Handshake Meeting 400
Agilent secures expanded CE Mark for cancer assay
By LabPulse.com staff writers
The test may now be used to identify esophageal cancer patients eligible for treatment with Keytruda, a monoclonal antibody developed by Merck that boosts the body's ability to fight cancer cells.
August 22, 2021
2020 04 14 17 10 6379 Test Tubes Rd Lab 400
Perspectum and Paige partner up to improve workflow in trials
By LabPulse.com staff writers
The partnership will bring together Perspectum's digital pathology service and integrated repository platform for both noninvasive and histology datasets and Paige's digital pathology software platform and software tools, the companies said.
August 5, 2021
2020 07 02 23 31 0378 Handshake Meeting 400
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