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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SARS-CoV-2 Detection Assays Highlight List of Key New Product Approvals
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FDA Finalizes CLIA Waiver Guidance for Approval of New In Vitro Diagnostic Devices
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Top of the News: CMS Issues New Guidance for Laboratories Performing Coronavirus Testing
On Feb. 4, the Food and Drug Administration (FDA) granted emergency use authorization (EUA) clearance for the first test approved in the US for detecting the novel coronavirus. Developed by the US Centers for Disease Control and Prevention (CDC) using sequencing...
FDA Watch: Agency Grants Emergency Clearance for CDC Novel Coronavirus Detection Test
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Agency to Use EUA Pathway to Clear New Coronavirus Detection Tests
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Lab Companies Scramble to Bring Coronavirus Detection Tests to Market
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FDA Watch: Agency Exempts Dozens of Tests from 510(k) Review
On Dec. 30, 2019, the U.S. Food and Drug Administration (FDA) published a final order exempting dozens of Class I and Class II medical devices that previously required 510(k) submission from 510(k) premarket review
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FDA Watch: Agency Targets Sale of IVD Reagents without Premarket Approval
Distribution of diagnostics and devices without premarket approval has featured prominently on the FDA’s enforcement priority list this year. The agency has issued seven warning letters related to premarket approval in 2019 after issuing just one such warning letter in all of 2018.
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Zika Antibody Detection Tests Go from Emergency to Commercial Clearance
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Emerging Tests: New Genetic Tests May Be Better than PSA Screening in Assessing Prostate Cancer Risk
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