There’s no argument that breakthrough medical devices have the potential to bring life-saving technology to patients. But the best way to get these devices covered under Medicare so beneficiaries can reap the promises they hold is not so clear.
AdvaMed Urges CMS To Leave MCIT In Place
In a letter to CMS Administrator Chiquita Brooks-LaSure, the industry association argues that repealing MCIT would deny many Americans access to “transformational” medical technologies.
More from Legislation
• By
Energy and Commerce Health Subcommittee Democrats focus on criticizing HHS Secretary Kennedy’s RIF announcement, including 3,500 FDA jobs among cuts across HHS agencies. Representatives were left wondering if user fee programs would continue, even if reauthorized.
AdvaMed’s top priorities for the 119th Congress include modernizing US Medicare services and expanding patients’ access to the latest medical technologies.
• By
A federal judge in Texas delivered what is most likely a fatal blow to the US FDA’s final rule, which would have regulated lab-developed tests as medical devices.
• By
President Trump’s CDC director nominee was pulled after vaccine positions appeared too extreme for some Republicans, but the nominations to lead the FDA and NIH advanced to the Senate floor despite last-minute drama.
More from Policy & Regulation
• By
A seemingly humorous social media post on April Fool’s Day struck a nerve with regulatory experts, reflecting real concerns about recent actions by the US Food and Drug Administration.
• By
Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.
• By
About 200 staff in the FDA’s Center for Devices and Radiological Health were among the 3,500 FDA employees let go in today’s staff reductions. The cuts, which one employee described as a “Manhattan Project” to the center, are already having a major effect on staff morale.