US commercialisation of FebriDx® to be discussed at Lumos Webinar: Thursday, June 11, at 10:30am AEST

Lumos Diagnostics Holdings Ltd (ASX:LDX, OTC:LDXHF) will host a virtual investor briefing on Thursday, June 11, at 10:30am ...
RAPS

CLIA Waiver Decisions: FDA Begins Posting Summaries

The US Food and Drug Administration (FDA) on Friday began posting decision summaries for its Clinical Laboratory Improvement Amendments (CLIA) waiver decisions for in vitro diagnostics (IVDs) as part ...
RAPS

FDA Finalizes Guidances on CLIA Waiver Applications, 510(k) Dual Submissions

The US Food and Drug Administration (FDA) on Tuesday finalized two guidances providing recommendation for diagnostics makers looking to submit Clinical Laboratories Improvement Amendments (CLIA) ...
Nasdaq

Axim Biotechnologies Files Pre-Submission With FDA for CLIA Waiver Pathway on Lactoferrin Point-of-Care Diagnostic Test

SAN DIEGO, CA - June 24, 2025 (NEWMEDIAWIRE) - Axim Biotechnologies, Inc. (OTCQB: AXIM), a leading developer of rapid diagnostic testing for ocular and systemic conditions, today announced that it has ...
JD Supra

What the New CLIA Rules Mean for Labs and At-Home Testing

New regulations under the Clinical Laboratory Improvement Amendments (CLIA) introduced updated proficiency testing (PT) and PT referral rules that are now in effect. Although the regulations became ...
JD Supra

CLIA Program Going Paperless March 1st – What You Should Be Doing Now to Prepare

The Centers for Medicare and Medicaid Services (CMS) announced that the Clinical Laboratory Improvement Amendments (CLIA) program will be paperless as of March 1, 2026. After this date, CMS will no ...
WNCT

CytoChip Receives FDA Clearance and First CLIA Waiver for a Cartridge-Based Complete Blood Count Test

The CLIA-waived CitoCBC® expands patient access to quick CBC results in physician offices, pharmacies, and home care, enabling data-driven diagnostics. CBC is one of the most commonly requested lab ...
La Grande Observer

Visby Medical™ Receives FDA Clearance and CLIA Waiver for Point-of-Care Respiratory Health Test

SAN JOSE, Calif., Feb. 26, 2025 /PRNewswire/ — Visby Medical ™ announced today that it has received 510(k) clearance and was granted a CLIA waiver from the U.S. Food and Drug Administration (FDA) for ...
MobiHealthNews

Theranos secures FDA waiver to take its blood tests out of the lab

Palo Alto-based novel blood test company Theranos was granted a waiver from the FDA allowing the company to offer its first FDA-cleared blood test, its herpes simplex 1 virus IgG (HSV IgG) test, ...
Nasdaq

Cepheid Receives Expanded FDA Clearance with CLIA Waiver for Xpert® Xpress MVP

SUNNYVALE, Calif., Jan. 18, 2024 /PRNewswire/ -- Cepheid announced today that it has received FDA Clearance with Clinical Laboratory Improvement Amendments (CLIA) waiver for Xpert® Xpress MVP. This ...