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
FDA-dtet
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
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
FDA Reports Progress in Advancing Regulatory Science for Diagnostics
From - Diagnostic Testing & Emerging Technologies
The U.S. Food and Drug Administration (FDA) recently unveiled its FY 2015-2016: Regulatory Science Progress Report. The report, the second of its kind under the…
FDA Speeding Approval Process, Continued User Fees Needed
From - Diagnostic Testing & Emerging Technologies
The U.S. Food and Drug Administration (FDA) is plagued with chronic understaffing, scrutiny over the length of time for approvals, and an expanding workload, while also…
Testing Recommendations Expand as Zika Season Approaches
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FDA Approves First-Ever, Pan-Cancer Drug in Milestone for Personalized Medicine
From - Diagnostic Testing & Emerging Technologies
In what is being heralded a major milestone for personalized medicine, in late May the U.S. Food and Drug Administration (FDA) approved the first…
FDA Reclassifies Rapid Flu Antigen Tests
From - Diagnostic Testing & Emerging Technologies
Effective mid-February the U.S. Food and Drug Administration (FDA) is reclassifying antigen-based, rapid influenza virus antigen detection test systems (RIDTs) used…
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