Regulations and Reimbursement of Software as a Medical Device in Europe- Part1

WASHINGTON, D.C.—AdvaMed, the world’s largest trade association representing medtech innovators, today urged the Centers for Medicare and Medicaid Services (CMS) to fix “serious flaws” in its proposed rule to restart competitive bidding for durable medical equipment in Medicare, citing risks to patient safety, fewer product choices for beneficiaries, and cost increases that would result if the rule stands. 

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. 

Member-only overview of IEEPA reciprocal & “fentanyl” tariffs under EO 14257, summarizing key federal court challenges and rulings through August 15, 2025.

A powerful op-ed from AdvaMed’s CEO explaining why tariffs could undermine U.S. medtech innovation, jobs, and patient care—and what must be done.

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.

AdvaMed, the medtech association, released the following statement today from Shaye Mandle, executive director of the organization’s Digital Health Tech division, on the announcement from the White House, CMS, and HHS of a voluntary pledge by health care entities to make patient data more accessible and delivered faster between patients and providers.

WASHINGTON, D.C. – In a new op-ed in The Washington Times, Scott Whitaker, president and CEO of AdvaMed, the Medtech Association, laid out medtech’s vital role in the Trump administration’s “Make America Healthy Again” initiative, calling for policies that ensure faster, broader access to lifesaving medtech.