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
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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
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Diagnostics Pipeline: MyOme and Artera Launch New Tests for Prostate Cancer Risk
The two assays identify threats prior to prostate cancer being diagnosed and after it has undergone extensive treatment, respectively
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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
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