Getting Started with the FDA’s New LDT Rule
Experts explain what the phase-in process will look like—and how labs can get ahead of the game.
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Lab Company Takes Rare Step to Promote Heart Disease Test
Publishing peer-reviewed studies to tout the economic benefits of medical devices is fairly commonplace, but rare for a laboratory company
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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
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3 Thoughts on the FDA’s Final LDTs Rule
Regulatory expert Julie Ballard shares her first thoughts on the final rule for lab-developed tests and immediate steps for labs
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
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