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-nir
Subscribe today for access to
Articles and Reports
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
FDA Sounds the Warning on Use of Unauthorized SARS-CoV-2 Rapid Tests
...
Already a member? Log in here
Don’t Use These Rapid COVID-19 Tests, FDA Warns
The US Food and Drug Administration recently issued a letter warning people not to use two different tests produced by Empowered Diagnostics.
FDA Lists 27 Current COVID-19 Tests that May Not Detect Omicron
...
Already a member? Log in here
HHS Reinstates FDA Premarket Review of LDTs
...
Already a member? Log in here
FDA Expands Recall of Ellume COVID-19 Home Test Kits
...
Already a member? Log in here
FDA Targets High Throughput COVID-19 Tests for Recall Due to Risks of False Positives
...
Already a member? Log in here
FDA Hikes Premarket Application User Fees by 2.5 Percent
...
Already a member? Log in here
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
