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
Author Information
Ron Shinkman
Ron Shinkman is a veteran journalist and editor, with more than 20 years of experience in the healthcare business realm. He served as Los Angeles bureau chief of Modern Healthcare, and also wrote for the Los Angeles and Orange County Business Journals.
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CDC-nirCLIA-lcaCLIA-nirCMS-lcaCMS-lirCMS-nirEssentialFDA-lcaFDA-lirFDA-nirLab Industry AdvisorRon Shinkman
HHS Suddenly Dismantles CLIAC After 33 Years
The board was eliminated as part of a sweeping reordering of the Department of Health and Human Services
FDA Watch: CDRH Budget May Not See Steep Cuts in FY 2026
A leaked budget document for the next fiscal year suggested non-user fee funding may be up slightly compared to recent years.
Dx Deals: Quest Diagnostics M&A Centers on Precision-Focused Approach
Recent inroads into testing of water for dialysis equipment illustrates Quest’s expanded scope with deals
Diagnostics Pipeline: Savara Introduces Blood Test to Detect aPAP, a Rare Lung Disorder
Savara’s ClearPath assay needs just a few drops of blood to test for aPAP, a condition that can be difficult and invasive to diagnose
FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
Further Details to Note about Updated Clinical Lab Director Qualifications
Put into place late last year, the new rules place more emphasis on formal and continuing education requirements
Clinical Diagnostics InsiderDiagnostic Testing and Emerging TechnologiesEmerging Tests-dtetRon Shinkman
Diagnostics Pipeline: Roche’s New Cobas Liat Panel Can Test for Multiple STIs Simultaneously
The PCR-driven test provides results in about 20 minutes in non-laboratory settings
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Dx Deals: BD Laboratory Business Is Up for Grabs in Bold Move
Becton Dickinson divisions responsible for $3.4 billion in annual revenue are on the block
MeMed Sepsis Test Gains Breakthrough Device Designation
The 15-minute assay to detect sepsis and assess its severity and risk is expected to get full FDA approval by 2026
