Top Five Articles on 360Dx Last Week: Routine Testing at the POC; FDA Plans to Reclassify IVDs; More
Last week, readers were most interested in a story about progress being made by diagnostic firms to bring routine testing to the point of care.
The firm's Wave platform uses digital holographic microscopy to return antimicrobial susceptibility test results within five hours.
The Vitros syphilis test qualitatively determines total antibodies to Treponema pallidum-specific antigens in serum and plasma.
Derm-Jes had acquired substantially all DermTech assets through a court-approved auction following DermTech's bankruptcy filing in June.
The firm is shifting its focus away from the Paige Platform ecosystem and toward incorporating its AI-based tests onto other companies' digital pathology systems.
The digital pathology firm's AISight Dx Image Management System is used to manage pathology slide images and caseloads and to aid primary diagnosis.
The companies will use Foundation's RNA sequencing platform to develop a companion diagnostic for Merus' bispecific antibody zenocutuzumab.
The Helsinki-based firm said that the money will support the US commercialization of its tests for nicotinamide adenine dinucleotide metabolites.
NEW YORK – The US Department of Health and Human Services will once again provide free at-home tests for SARS-CoV-2 to US residents, the agency said last week. Already have a 360Dx or GenomeWeb or ...
Last week, readers were most interested in a story about draft guidance from the FDA on modifying medical devices without needing another round of regulatory review.
The production facility focuses on the manufacturing of diagnostic products mainly for China and parts of Asia-Pacific.
The US FDA granted clearance to hematology analyzers and assays for chronic, emergency, and infectious disease uses, among other tests and instruments.
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