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 Takes Steps to Promote Scientifically Sound Development of AI-Based Medical Devices
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Agency Tells EUA SARS-CoV-2 Test Makers to Account for Viral Mutations
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Final Rule Clarifies Liability for Off-Label Uses and Lab’s Right to Create LDTs
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FDA Watch: VALID and VITAL Bills for LDTs Regulation Are Back in Play
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First Ever Approval of COVID-19 Blood Spot Self-Collection & Molecular Test Pooling
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Manufacturers Wait Anxiously for CMS Decision on Automatic Medicare Coverage of MCIT Breakthrough Devices
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Agency Okays COVID-19 Blood Spot Self-Collection & Molecular Test Pooling
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Manufacturers Wait Anxiously for CMS Decision on Automatic Medicare Coverage of MCIT Breakthrough Devices
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Agency Okays COVID-19 Blood Spot Self-Collection & Molecular Test Pooling
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Agency Opens Premarket Pathway for Post-Emergency COVID-19 Test Marketing
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