CovarsaDx® to Exhibit at ADLM 2026 — Booth #1477
Anaheim Convention Center | Anaheim, CA | July 26–30, 2026 LAS VEGAS, NV—July 15, 2026 —CovarsaDx®, a contract research organization […]
Press Releases
CovarsaDx Appoints Mark Boyle as Chief Operations Officer to Accelerate Global Growth in IVD and Medical Device Clinical Research
Las Vegas, NV — CovarsaDx, a leading clinical research organization (CRO) focused exclusively on in vitro diagnostics (IVDs) and medical
CovarsaDx Appoints Dr. Karen Shannon as In-House Counsel to Support Continued Growth, Compliance and Innovation
CovarsaDx, a leading contract research organization (CRO) specializing in the areas of in vitro diagnostics (IVD) and medical device clinical
CovarsaDx to Highlight Integrated Clinical Trial Expertise at ADLM 2025
CovarsaDx to Highlight Integrated Clinical Trial Expertise at ADLM 2025 CovarsaDx, a leading medical device and diagnostics clinical research organization
CovarsaDx Strengthens Regulatory Expertise with Industry Veteran David Ikeda
Los Angeles, Calif., February 10, 2025 – CovarsaDx, a prominent Clinical Research Organization (CRO) well-known for its expertise in the areas
CovarsaDx® Research Team Provides Key Support for the FDA 510(k) Clearance for OSANG Healthcare’s Over-The-Counter QuickFinder™ COVID-19/Flu Antigen Self-Test and QuickFinder™ COVID-19/Flu Antigen Pro Test
CovarsaDx®, a prominent Clinical Research Organization (CRO) renowned for its expertise in the areas of in-vitro diagnostics (IVDs) and medical
Nuclein’s DASH® SARS-CoV-2 & Flu A/B Test for Use on the DASH® Rapid PCR System Receives FDA 510(k) Clearance and CLIA Waiver with Key Support from CovarsaDx® Research Team
CovarsaDx®, a prominent Clinical Research Organization (CRO) renowned for its in vitro diagnostics (IVDs) and medical device expertise, announced today that one of its clinical research study clients, Nuclein, LLC, has received U.S. Food and Drug Administration (FDA) 510(k) clearance and a Clinical Laboratory Improvement Amendments (CLIA) waiver for the DASH® SARS-CoV-2 & Flu A/B Test for use on the DASH® Rapid PCR System.
Healgen’s At-Home COVID-19 and Influenza Test Achieves FDA De NovoStatus with Key Support from CovarsaDx® Research Team
CovarsaDx®, a prominent Clinical Research Organization (CRO) renowned for its expertise in the areas of in vitro diagnostics (IVDs) and medical devices, proudly announced today that a clinical research study, conducted on behalf of Healgen Scientific, LLC, through the Independent Test Assessment Program (ITAP), part of National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx®) Tech, has received De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) for the Healgen Rapid Check® COVID-19/Flu A&B Antigen Test.
CovarsaDx Expands Collaborative Efforts Through MDIC Membership and Key Initiatives
CovarsaDx is proud to announce its membership in the Medical Device Innovation Consortium (MDIC). This partnership marks a significant milestone in CovarsaDx’s ongoing mission to advance innovation in healthcare technology by providing reliable clinical validation results from an elite network of experienced investigators.