The 2022 Year in FDA 510(k) Approvals
Roche and Abbott received the most approvals for new lab tests last year.
How to Resolve Three Common Types of Preanalytical Interference
Experts share new strategies for dealing with hemolysis, icterus, and lipemia interference.
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Easier, Noninvasive Diagnosis of Neurological Disorders
More companies have begun offering neurofilament light chain blood tests as a cost-effective alternative to conventional methods.
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Roche Scores First European IVDR Approval for Diagnostic Tests
The test manufacturer is the first to gain IVDR certification for a companion diagnostic under the new regulation.
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Early in Pandemic, HIV Testing Dropped Sharply, but Quickly Rebounded
A recent CDC report concludes that disruptions to HIV testing due to the COVID-19 pandemic compromised America’s ability to prevent the disease.
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