Legislation
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.
Democrats are raising concerns that the continuing resolution intended to fund the government for the remainder of fiscal year 2025 gives Trump too much power, though it is unclear whether the FDA would be as impacted as other agencies.
In response to the Trump administration increasing its tariffs on imports from China, Beijing announced a ban on gene sequencers from US biotech firm Illumina, signaling a full-blown trade war could be in the making. Trump also pushed the deadline for implementing tariffs on Canada and Mexico back by another month.
The FDA commissioner nominee offered few details on device policy, but said he was open to funding device postmarket surveillance through user fees. He also offered some defense of staff cuts while saying he would perform his own assessment before planning any more.
ACLA wants policymakers to see the vital role clinical labs play in delivering better health outcomes for patients and improving public health, especially in their potential for catching diseases early.
The director of the US FDA’s device center is sounding the alarm on the scarcity of critical devices for pediatric patients and says the agency is focused on solutions to this “unique” challenge.
The US FDA has finalized guidance on notifying the agency of potential device shortages during or prior to a public health emergency. The document includes a list of devices that manufacturers must notify the FDA of when they are in short supply. The guidance also clarifies that device makers voluntarily notify the agency of potential supply chain disruptions at any time.
The medtech industry played a pivotal role in the first Trump administration, most notably during the COVID-19 pandemic. But the sector was also impacted by the administration’s deregulation push and trade posture towards China, including tariffs. So, should stakeholders expect more of the same in a second Trump term, or brace for uncertainty and change?
A US House Oversight Committee report criticizes the government's COVID-19 response, including PPE shortages and issues with the CDC’s test development process. However, it praises the successful public-private partnerships in developing diagnostics, emphasizing the importance of leveraging private industry expertise for future pandemic preparedness.
Illumina's successful appeal to the European Court of Justice could transform life science transactions. However, the ruling has notable limitations and further jurisdictional stretch from the European Commission is expected, said Latham and Watkins lawyers at the Jefferies London Healthcare Conference.
The US Senate is considering a bill to expand Medicare coverage for breakthrough devices and diagnostics, removing the five-per-year limit imposed by CMS’ Transitional Coverage for Emerging Technology (TCET).
At a recent Washington, DC conference, key government figures expressed optimism that bipartisan efforts will continue to drive advancements in medical technology, even amidst political challenges. They also emphasized the importance of supporting ARPA-H and BARDA initiatives.
Robert F. Kennedy Jr.'s nomination to lead the US Department of Health and Human Services has generated both cautious optimism and concerns in the medtech sector, with concerns including a less science-based regulatory environment and potential user fee cuts.
Donald Trump’s victory in the US presidential election once again is creating a potentially unsettling transition process for the FDA. While it is far from clear that the new administration actually will want to disrupt the agency, there are several ways it could happen.
France’s medtech sector is strong, growing and innovative. Medtech Insight spoke to several French medtech leaders about the unique features and pitfalls their industry may face.
Republican presidential candidate Donald Trump says he will let Robert F. Kennedy Jr. “go wild on medicines” if he wins the White House. That could spell challenges for the US FDA in 2025.
The European Parliament is making a formal appeal to the European Commission to accelerate its EU MDR revision plans.
The College of American Pathologists wants a US district court to scrap the FDA’s final rule that unilaterally assumes oversight of lab-developed tests, but not because the college feels the agency has no business regulating them. Helena Duncan, senior director of quality at CAP, explained the college’s position to Medtech Insight.
Highlights from Medtech Insight's on-the-ground coverage of LSX in Boston.
In a letter to US lawmakers, the Association for Diagnostics and Laboratory Medicine says the FDA’s final rule regulating lab-developed tests will stifle innovation and that Congress needs to step in and stop it.