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
Agency Finalizes Rule on Off-Label Uses Liability and Rights of Laboratories to Create LDTs
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Agency Imposes 2.5 Percent Increase in 2022 Premarket Application User Fees
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FDA Regulation of COVID-19 Testing Enters a New Phase
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First Ever Approval of COVID-19 Blood Spot Self-Collection & Molecular Test Pooling
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Newly Reintroduced VITAL Act Would Strip Agency of LDT Regulatory Authority
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New Study Supports Use of Liquid Biopsy Technology to Bolster MRI Accuracy in Cancer Treatment
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2020 Was a Record Year for New Medical Device Approvals—And Not Just for COVID-19
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