CASE STUDY: Accelerating IVD and Medical Device Research with Mednet
CovarsaDx, a leader in IVD and medical device clinical trials, faced a common challenge: efficiently managing vast amounts of complex […]
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.
CovarsaDx’s 2024 Year in Review: Pioneering Progress, Partnerships, and People
As we reflect on 2024, CovarsaDx has much to celebrate. This year was marked by milestones that showcased our commitment to advancing diagnostic innovation
Rebuilding Trust in Clinical Research: Addressing Misinformation and Ethical Standards
Clinical research, especially in the fields of in-vitro diagnostics (IVD) and medical devices, plays a vital role in advancing healthcare solutions and improving public health. However, a pervasive issue facing the industry is the erosion of public trust due to misinformation and past ethical missteps such as the Tuskegee Syphilis Study.
CovarsaDx Welcomes Tania Vogel: A Leader in Regulatory and Quality Assurance Excellence
CovarsaDx is thrilled to welcome Tania Vogel to the team as our newest leader in Regulatory and Quality Assurance. With a career spanning nearly two decades and a resume that reads like a blueprint
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.