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.
The test is expected to be used by payors and healthcare systems to identify people most likely to respond to the weight-loss drugs.
The company beat analysts' average estimates on the top and bottom lines and guided to $7.3 billion to $7.4 billion in revenues for fiscal 2026.
With the permit, St. Louis-based C2N can offer its PrecivityAD2 and PrecivityAD Alzheimer's blood tests to patients in New York state.
NEW YORK – What were the articles that gained the most interest from 360Dx readers last week? Here are the top five: ...
PrognomiQ announced the initial launch of its ProVue blood test while Mercy presented new data detailing the performance of its Halo lung cancer test.
The firm's new strategy revolves around adding to its test menu in an impactful way and expanding its installed base of instruments.
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