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
FDA-nir
Subscribe today for access to
Articles and Reports
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
FDA Hikes Premarket Application User Fees by 2.5 Percent
...
Already a member? Log in here
FDA Clears the Way for Over-the-Counter Sale of COVID-19 Home Test Kits
...
Already a member? Log in here
FDA Sounds Alarm on Potential Impact of Genetic Mutation on SARS-CoV-2 Molecular Test Accuracy
...
Already a member? Log in here
FDA Clears the Way for Over-the-Counter Sale of COVID-19 Home Test Kits
...
Already a member? Log in here
The FDA Drops a Bombshell: No More EUA Review of COVID-19 LDTs
...
Already a member? Log in here
FDA Breaks New Ground by Authorizing SARS-CoV-2 Tests for Sample Pooling
...
Already a member? Log in here
FDA Warns of False-Positives from Becton Dickinson SARS-CoV-2 Test & Reagents
...
Already a member? Log in here