The agency would down-classify nucleic acid-based tests for use with a corresponding approved therapy product to Class II devices from Class III.
The US Food and Drug Administration granted clearances for PCR-based infectious disease tests from multiple companies as well as other in vitro diagnostic tests.
InnotiveDx's UTI diagnostic technology provides bacterial identification and antimicrobial susceptibility test results in less than 60 minutes.
NEW YORK – Agilent Technologies said after the close of the market Monday that its fiscal fourth quarter revenues grew 9 percent year over year. For the three months ended Oct. 31, the Santa Clara, ...
The test is expected to be used by payors and healthcare systems to identify people most likely to respond to the weight-loss drugs.
NEW YORK – What were the articles that gained the most interest from 360Dx readers last week? Here are the top five: ...
NEW YORK – Alzheimer's testing firm C2N Diagnostics said Monday that it has received a laboratory permit from the New York State Department of Health's Clinical Laboratory Evaluation Program (CLEP).
A slew of new studies and reports suggest that new molecular approaches may soon help reduce the global burden of tuberculosis.
PrognomiQ announced the initial launch of its ProVue blood test while Mercy presented new data detailing the performance of its Halo lung cancer test.
NEW YORK – Siemens Healthineers is planning a flurry of new assay launches in its diagnostics segment for 2026 as it looks to consolidate its portfolio and streamline operations to align with a new ...
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