Device Regulation and Policy

CMS establishes a national payment for AI ECG analysis, paving the way for enhanced cardiovascular diagnostics and early patient intervention.

FDA's AI tool, Elsa, faces scrutiny for producing unreliable data, raising concerns about its rapid implementation and impact on regulatory accuracy.

U.S. tariffs are disrupting European medtech growth, forcing firms to adapt supply chains and prioritize cost optimization amid rising challenges and uncertainties.

Medtech CEO warns senate that tariffs could undermine health care and innovation

Scott Whitaker says tariff-free trade is critical to maintaining the industry’s competitiveness and ensuring patient access to lifesaving products

Experts say the lack of a consistent payment mechanism through Medicare has become a major roadblock to adoption.

Association previously expressed grave concerns about the effect of tarrifs.

Groups say that tariffs could unfairly jeopardize patient care

Between President Trump's tariff plan and sweeping layoffs at the FDA and HSS, the medical device industry is facing an uncertain future.

‘The revolution begins today,’ new HHS Secretary RFK Jr. says.

Merged organizations pledge to advance innovative technologies to improve patient care.

Imported components account for almost half of US companies’ FDA-approved products

Media report highlights how FDA workloads have increased, and delays for new technology approvals will likely suffer

AdvaMed, the Advanced Medical Technology Association, the trade group for medical device manufacturers, released a list of priorities for Congress. Here are some of the key objectives.

President Trump says it’s necessary to impose extra costs on goods from Canada, Mexico and China. What does that mean for the health care sector? Potentially, a lot.

AdvaMed, Senate Democrats warn of regulatory slowdowns and public health threats following mass layoffs at the FDA.

AdvaMed points to supply chain risks if tariffs are applied to medical devices