AdvaMedDx Cohosts Briefing Session with CDC Mycotic Diseases Branch

One of healthcare’s most extensive and rapidly expanding market segments, Pointof-Care (POC) and at-home rapid diagnostic testing, has become an ever-increasing crucial topic in the medical world since COVID-19 was first declared a pandemic.

Today, Zach Rothstein, Executive Director of AdvaMedDx, testified before the House Energy and Commerce Committee, Subcommittee on Health during a hearing on diagnostic test regulation and FDA’s proposed laboratory developed test (LDT) rule.

This February, AdvaMed is working with member companies and our global partners to raise awareness and highlight the ways medical technology helps those living with cardiovascular disease live healthier, happier lives.

Today, AdvaMedDx submitted comments in response to the Food and Drug Administration’s Proposed Rule: Medical Devices; Laboratory Developed Tests. AdvaMedDx is a division of AdvaMed representing companies that develop in vitro diagnostic (IVD) tests.

Today, AdvaMedDx, a division of AdvaMed representing manufacturers of innovative in vitro diagnostic tests, sent a letter urging Congressional leaders to prioritize the reauthorization of the President’s Emergency Plan for AIDS Relief (PEPFAR) program. PEPFAR funding lapsed at the end of the fiscal year 2023.

AdvaMed, the Medtech Association, released the following statement from President and CEO Scott Whitaker and Zach Rothstein, Executive Director of AdvaMedDx, on FDA’s recently proposed LDT rule.

The Dx Summit convenes leaders from the IVD and clinical diagnostic lab community to explore the most significant policies, technologies, and market shifts in the industry.

Today, AdvaMed, the MedTech Association, released updated reports, in collaboration with Deloitte on frameworks for the comprehensive assessment of medical technologies and diagnostic tests. These seminal reports had been developed to help key stakeholders—payers, providers, health technology assessment bodies, patient advocates, and medtech companies – to assess the value of medical technologies in an emerging value-based care world.