Ron Shinkman

Los Angeles

Writer and Editor at Freelance

Editor and Reporter at Health Payer Specialist

Editor and Reporter at Financial Times

Articles

Diagnostics Pipeline: FDA Approves Visby Medical’s Over-The-Counter Women’s Sexual Health Test

3 weeks ago | g2intelligence.com | Ron Shinkman

It’s the first PCR-based sexually transmitted infection test platform for at-home use
HHS Suddenly Dismantles CLIAC After 33 Years

4 weeks ago | g2intelligence.com | Ron Shinkman

The US Department of Health and Human Services (HHS) has quietly and swiftly eliminated the Clinical Laboratory Improvement Advisory Committee (CLIAC), raising concerns in the laboratory sector that critical policy, safety, and health issues may be overlooked or neglected by the federal government.
FDA Watch: CDRH Budget May Not See Steep Cuts in FY 2026

1 month ago | g2intelligence.com | Ron Shinkman

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

1 month ago | g2intelligence.com | Ron Shinkman

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

2 months ago | g2intelligence.com | Ron Shinkman

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

Mar 28, 2025 | g2intelligence.com | Ron Shinkman

Pre-submission and Q-Submission meetings apparently have been halted, for now
Further Details to Note about Updated Clinical Lab Director Qualifications

Mar 20, 2025 | g2intelligence.com | Ron Shinkman

by | Mar 20, 2025 | CLIA-lca, CLIA-nir, CMS-lca, CMS-nir, Compliance-lca, Employment-lca, Lab Industry Advisor Put into place late last year, the new rules place more emphasis on formal and continuing education requirements Put into place late last year, the new rules place more emphasis on formal and continuing education requirements Subscribe to View Start a Free Trial for immediate access to this article...
Diagnostics Pipeline: Roche’s New Cobas Liat Panel Can Test for Multiple STIs Simultaneously

Mar 11, 2025 | g2intelligence.com | Ron Shinkman

The PCR-driven test provides results in about 20 minutes in non-laboratory settings
Dx Deals: BD Laboratory Business Is Up for Grabs in Bold Move

Feb 28, 2025 | g2intelligence.com | Ron Shinkman

Becton Dickinson divisions responsible for $3.4 billion in annual revenue are on the block
MeMed Sepsis Test Gains Breakthrough Device Designation

Jan 31, 2025 | g2intelligence.com | Ron Shinkman

The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to a new test from Israeli firm MeMed that can diagnose a suspected case of sepsis within minutes.1 Sepsis is the body’s severe inflammatory reaction to an infection. This inflammation can lead to clots in blood vessels, hampering blood flow to the body’s internal organs.

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