North America
HHS Secretary Robert F. Kennedy Jr. urged FDA staff to resist the “deep state” and “crony capitalism,” and focus on improving the health of America’s children. “You're not here to take orders,” he said and urged FDA staff to speak up if they see wrongdoing.
The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.
The medtech industry hopes to use a 90-day pause on tariffs to negotiate a “zero for zero” exemption. However, recent public comments from President Donald Trump suggest the health care sector may still be at risk.
Nawal Ouzren, Sensorion CEO and director, shared the latest industry reaction to US FDA layoffs at the McDermott Will & Emery European Health and Life Sciences Symposium in Paris.
A concealed blunt-tip needle that can be inserted into the heart's pericardial space to treat cardiac arrhythmias has received FDA clearance, providing an alternative to catheter-based methods.
The FDA staff cuts will probably mean longer device review times at least in the short term, speakers said at a recent webinar. But innovations like AI and third-party review could offer some hope, even as tariffs create a new set of problems.
Product reviews for drugs, biologics, devices, tobacco and foods could be consolidated into one office at the FDA, as part of a restructuring plan circulating that was obtained by Pink Sheet.
Now that a federal judge has ruled the US FDA exceeded its authority by unilaterally assuming regulatory oversight of lab-developed tests, what’s the agency’s next move? And does it really have one?
US President Trump has imposed sweeping tariffs that encompass medtech. These are expected to drive up costs, disrupt supply chains and hinder innovation, likely driving the EU to seek new trade partnerships to mitigate the impact.
Medical devices, diagnostics, and equipment face tariffs announced by President Donald Trump, despite industry pleas for exemption. The tariffs, ranging from 10%-49%, impact most countries trading with the US, potentially hindering innovation and increasing costs in the medtech sector.
The US FDA has published its final document to guide sponsors on using sex-specific data in designing clinical trials of medical devices. However, the guidance removes all references to gender that appeared in January’s draft guidance, released before the Trump administration took office.
Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders.
Some employees were not impressed with FDA Commissioner Martin Makary's first speech to the agency staff, saying he did not seem to understand the agency's mission.
Swiss medtech exporters seek urgent diplomatic action from the Swiss Federal Council in a bid to overturn the 2 April US decision to put tariffs on goods imports.
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.
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.
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.
AdvaMed’s top priorities for the 119th Congress include modernizing US Medicare services and expanding patients’ access to the latest medical technologies.
Abbott presented late-breaking data at the 2025 American College of Cardiology conference demonstrating that TriClip transcatheter edge-to-edge repair offers prolonged patient benefits compared to medical treatment alone after two years, which were not evident at one year.
The Cologuard Plus test has a sensitivity of 95% and a specificity of 94% for the detection of colorectal cancer; “unmatched accuracy,” according to Exact Sciences.