FDA Watch: FDA Moves Slowly on AI-Driven Lab Devices
The agency has approved fewer than 10 tests in the past three years, but a new pipeline of AI-powered products is expected to emerge soon
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FDA Issues Four Warning Letters to Lab Companies in Less Than Two Months
Laboratory diagnostics manufacturers receive regulatory scrutiny for issues including marketing, quality, and unapproved changes to tests
FDA Watch: AI-Based Sepsis Prediction Test Receives FDA Authorization
Prenosis claims its test can detect the presence of the often deadly condition within 24 hours of a hospitalization
Agency Clears Record Number of New Medical Devices in 2020
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Ortho Clinical Diagnostics Gets Green Light for Mass SARS-CoV-2 Antigen Test
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Agency Greenlights First Over-the-Counter, At-Home COVID-19 Testing Kit
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Lucira Health Secures First EUA for Fully At-Home COVID-19 Testing Kit
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Agency Temporarily Allows Modifications of Influenza and RSV Tests Without Premarket Notification
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Respiratory Panel Tests Flow from EUA Pipeline Ahead of Flu Season
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Saliva COVID-19 Tests Offer Way Around Nasopharyngeal Swab Shortage Bottlenecks
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FDA Offers New Guidance on Validating SARS-CoV-2 Tests in “Non-Laboratory” Settings
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Agency Green Lights First SARS-CoV-2 Tests for Sample Pooling
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Agency Sounds the Warning on False-Positives from Becton Dickinson SARS-CoV-2 Reagents
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