Esophageal Pre-Cancer Testing Gaining Greater Traction
How three companies are addressing screening challenges with tests that help improve chances of early detection
FDA-dtet
Has Your AI Been Validated?
Many artificial intelligence-based medical devices have not undergone clinical validation—but what does this mean for the lab?
Diagnostics Pipeline: Recent FDA Approvals Aim to Make HPV Testing for Women More Accessible
Expansion of use for two assays gives patients the option to self-collect specimens at home and in the clinic, which may help address gaps in screening
Agency Temporarily Allows Modifications of Influenza and RSV Tests Without Premarket Notification
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FDA Pulls the Plug on EUA Review of Laboratory Developed Tests for COVID-19
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Agency to Provide Emergency Clearance for Multi-Analyte Respiratory Panels
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HHS Clears the Way for Use of New COVID-19 Tests without FDA Emergency Use Authorization
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FDA Cracks Down on Improper Marketing of SARS-CoV-2 Antibody Tests
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First Enforcement Action for Improper Marketing of SARS-CoV-2 Antibody Tests
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FDA Sets the Bar on Specimen Pooling & Asymptomatic Screening for SARS-CoV-2 Test Development
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After Initial Resistance, Agency Warms to Home COVID-19 Testing
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Now Even the “Good” Tests Are Coming Under Fire
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Agency Clears Dozens of New COVID-19 Diagnostic Tests in Record Time
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