Guardant Health’s Shield™ Blood Test Approved by FDA as a Primary Screening Option, Clearing Path for Medicare Reimbursement and a New Era of Colorectal Cancer Screening

Christopher L. White, Esq., AdvaMed’s General Counsel & Chief Policy Officer, on why this year’s legal, compliance & regulatory programming is mission-critical as medtech leaders navigate uncertainty, shifting enforcement priorities, and a rapidly changing global legal landscape.

WASHINGTON, D.C.—AdvaMed, the Medtech Association, is among 67 stakeholder groups, including patient advocacy groups and state medtech and life sciences associations, urging the Centers for Medicare and Medicaid Services (CMS) to create a timely, streamlined pathway for Medicare patients to access FDA-authorized breakthrough medical technology. 

WASHINGTON, D.C.—AdvaMed, the medtech association, today welcomed the kickoff of the latest Medical Device User Fee Amendments (MDUFA) discussion at a public meeting at FDA headquarters. Three AdvaMed senior staff members encouraged the agency to build on the successes of the prior five such agreements to ensure the next agreement, MDUFA VI, delivers strong results for the American public.

Join cyber experts for the Cybersecurity Summit that will address the latest industry issues and changes related to FDA requirements.

AdvaMed President and CEO Scott Whitaker testified before the U.S. Senate Finance Committee, bringing attention to the pressing issue of how tariffs could impact the medtech industry and, most importantly, the patients who depend on it. 

At AdvaMed, we’re proud to be recognized for our work on behalf of the medtech community – and we’re especially grateful when that recognition comes from respected voices like Kwame Ulmer of MedTech Impact Partners and our colleagues at Orthogonal. 

Washington, D.C.—AdvaMed, the Medtech Association, today released its “AI Policy Roadmap,” a detailed policy outline for Congress and the federal agencies with jurisdiction over medtech to consider in promoting the next era of artificial intelligence-enabled medical and digital health technologies to provide patients and clinicians transformative new tools to aid in diagnosis and treatment. 

Washington, D.C.– AdvaMed®, the Medtech Association, today released the following statement from President and CEO Scott Whitaker on the U.S. Senate’s confirmation of Dr. Mehmet Oz to serve as Administrator of the U.S. Centers for Medicare and Medicaid Services.