FDA Watch: MeMed and NG Biotech Receive FDA Breakthrough Device Designations for Rapid Infection Tests
In both cases, the diagnostic tests report results back within 15 minutes
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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
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
Kellison Award goes to FDA’s Dr. Alberto Gutierrez
From - Laboratory Industry Report
Dr. Alberto Gutierrez is the 2017 recipient of the Kellison Lab Industry Distinguished Service Award. Dr. Guitierrez retired in August after…
Liquid Biopsies Get FDA Attention
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Congressional Leaders Query FDA and CMS about Theranos
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FDA Guidance Addresses NGS Testing, Espousing Flexibility in Oversight
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FDA’s LDT Oversight Framework Could Impact 60,000+ Tests
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FDA’s 2016 Guidance Plans Include LDTs and Other Diagnostics Topics
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