National Lab Companies Move Quickly to Market Fujirebio’s Lumipulse for Earlier Alzheimer’s Detection
The new blood-based assay avoids painful lumbar punctures and may quicken Alzheimer’s diagnoses
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FDA Approves Teal Wand as First At-Home Cervical Cancer Screening
Teal Health, the company manufacturing and distributing the test, says thousands of women are already on a waiting list for the assay
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Diagnostics Pipeline: FDA Approves Visby Medical’s Over-The-Counter Women’s Sexual Health Test
It’s the first PCR-based sexually transmitted infection test platform for at-home use
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2021 Was a Breakthrough Year for Breakthrough Devices Program
The FDA designated 213 submissions as breakthrough devices in 2021, the most awarded in a single year, by far.
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Scorecard: COVID-19 Rapid Test Recalls and Warnings in 2022
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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.
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FDA Points the Way to Transition EUA SARS-CoV-2 Tests to Full Approval
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Device Reclassification Order Opens 510(k) Pathway for HCV RNA and Antibodies Tests
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Agency Regains Its Authority to Regulate Laboratory Developed Tests (LDTs)
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FDA Imposes New Limits on COVID-19 Tests with Access to EUA Pathway
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Management Expert Report Cites Weaknesses in Agency’s EUA Processes
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False Positive Recalls Casts Doubt on Rapid COVID Screening Tests at the Worst Possible Time
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FDA Requires EUA SARS-CoV-2 Test Developers to Account for Viral Mutations
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