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 ...

Lumos pivots to commercial growth phase following FebriDx breakthrough

Lumos Diagnostics Holdings Ltd (ASX:LDX, OTC:LDXHF) has used its March quarter update to underline a period of operational ...

QuidelOrtho Corporation Completes Acquisition of LEX Diagnostics

QuidelOrtho Corporation (Nasdaq: QDEL) (the "Company" or "QuidelOrtho"), a global leader of innovative in vitro diagnostics, announced today it has completed the acquisition of LEX Diagnostics ("LEX") ...
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 ...
MarketWatch

Breaking the PCR-Only Barrier: Dual 510(k) Clearance and CLIA-Waiver Establish FINDER as the First Molecular Point-of-Care Platform with Multifunctional Capabilities

The MarketWatch News Department was not involved in the creation of this content. DURHAM, N.C., March 31, 2026 /PRNewswire/ -- Baebies announced FDA 510(k) clearance and CLIA-waiver approval for the ...
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 ...
Seeking Alpha

Cepheid Receives FDA Authorization with CLIA Waiver for Xpert® HCV

Detection of hepatitis C virus (HCV) in about an hour SUNNYVALE, Calif., June 27, 2024 /PRNewswire/ -- Cepheid announced today that it has received FDA De Novo marketing authorization and Clinical ...
Seeking Alpha

Lumos Diagnostics Holdings Limited (LDXHF) Discusses CLIA Waiver Clearance for FebriDx, Capital Raise, and Commercialization Strategy Transcript

Good morning, everyone, and welcome to the Lumos Diagnostics investor briefing to discuss the recent granting of CLIA for FebriDx and the capital raise. My name is George Kopsiaftis, and I'll be your ...
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, ...