The agency would down-classify nucleic acid-based tests for use with a corresponding approved therapy product to Class II devices from Class III.
InnotiveDx's UTI diagnostic technology provides bacterial identification and antimicrobial susceptibility test results in less than 60 minutes.
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.
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, ...
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).
The test is expected to be used by payors and healthcare systems to identify people most likely to respond to the weight-loss drugs.
A slew of new studies and reports suggest that new molecular approaches may soon help reduce the global burden of tuberculosis.
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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