Beyond EUA: FDA Grants 510(k) Clearance for a COVID-19 Test
On Jan. 27,...
COVID-19
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Medicare Will Pay for Over-the-Counter COVID-19 Tests
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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.
Professor Discusses His Work in Microfluidics, SARS-CoV-2 Sequencing
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Agency Continues Crack Down on Unauthorized COVID-19 Tests
On Jan. 11, the FDA warned consumers not to use COVID-19 tests from LuSys Laboratories, as they have not been approved for use in the US.
FDA Points the Way to Transition EUA SARS-CoV-2 Tests to Full Approval
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COVID-19 Testing Drives Increase in Part B Medicare Lab Spending
Here’s a look at the key takeaways from the Dec. 30 OIG report on Medicare Part B spending on lab testing.
White House Ups Effort to Resolve Rapid, At-Home COVID-19 Test Shortages
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President Orders Private Payors to Cover At-Home, Rapid COVID-19 Testing
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FDA Lists 27 Current COVID-19 Tests that May Not Detect Omicron
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Agency Regains Its Authority to Regulate Laboratory Developed Tests (LDTs)
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