ADLM Calls on Feds to Regulate AI in the Clinical Lab Sector
But anti-regulatory stance taken by Trump administration could serve as a potential obstacle in the effort
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FDA Watch: Truvian Health Obtains 10 Additional FDA Clearances for TruVerus Platform
TruVerus is designed to perform a slew of clinical laboratory tests on as few as eight drops of blood
FDA Watch: Truvian Health Receives Initial FDA Clearance for 34-Test Platform
San Diego-based healthcare diagnostics company is trying to succeed where Theranos failed
LDT Guidance Unlikely to Be Released Anytime Soon
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FDA to Review 23andMe 510(k) for Rare Syndrome
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Senators Request Release of FDA Lab Test Guidance
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Debate Continues Over FDA Regulation of LDTs
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Colon Cancer Screening Test Gets FDA Approval, Proposed Medicare Coverage
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FDA Plans to Regulate Lab-Developed Tests Could Increase Time and Cost of Development
In its July 31 notice to Congress, the agency says it would phase in oversight requirements over nine years.
FDA Official Defends Plan to Issue Guidance for LDTs
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FDA Lowers Risk Classifications For Bone Marrow, Diabetes Diagnostic Tests
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Lab Execs Air Concerns Over FDA Regulation of LDTs
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