Legislation
A recent study demonstrates that certain types of blood-based tests that screen for multiple cancers at once have the potential to flip the script on cancer diagnoses, including some of the deadliest types.
But the Senate’s reduction would not be as much as the House of Representatives and President Trump proposed earlier this year, which is likely a win for the agency.
Nearly one year into leading their agencies, US FDA Commission Marty Makary and CMS Administrator Mehmet Oz took to the stage together at the Milken Institute’s Future of Health Summit 2025 to highlight what they see as progress and lay out plans for the road ahead.
Advocates spanning the spectrum of women’s health met in Manhattan to discuss the gender disparities that remain in healthcare and how public policy can correct them and the enormous ROI investors in women’s health can potentially reap.
During a Senate hearing on Oct. 29, stakeholders advocated for FDA reforms to boost U.S. biotech innovation amid growing competition, particularly from China. Key recommendations included enhancing AI use, improving clinical trial processes, and streamlining regulatory practices.
Some of the first manufacturers to receive Medicare coverage for their breakthrough devices through the Transitional Coverage for Emerging Technologies pathway praise CMS’ engagement and timelines in the process, despite some challenges around post-launch data collection.
Europe’s medtech sector is actively supporting the European Commission’s push to cut red tape in environmental legislation. By offering practical solutions, the industry aims to ease regulatory burdens that have hindered innovation and competitiveness while maintaining patient safety.
Spain is drafting a new digital health bill that aims to ensure the country is ready to implement the European Health Data Space Regulation.
Bipartisan legislation pending in the US House aims to get FDA-designated breakthrough medical devices to patients with Medicare coverage more quickly.
AdvaMed has praised CMS’ Rural Health Transformation Program, which will allocate $50 billion over five years to enhance rural healthcare. States can apply for grants by Nov. 5 to develop sustainable healthcare systems and improve patient outcomes.
Roche’s scanners have been integrated with PathAI’s AISight Dx system. The system’s FDA-cleared PCCP allows new components to be validated and integrated without additional FDA clearance. Eric Walk, chief medical officer, hints at future biopharma companion diagnostic collaborations.
A recent conference panel discussed the stagnation in diagnostics regulation, highlighting the FDA's failed regulatory efforts on lab-developed tests. Political and legislative challenges hinder other reforms, and concerns over Medicare reimbursement cuts loom for the clinical lab industry.
EirMed CEO Richard Houlihan warns that EUDAMED (the European database on medical devices) publication delays may harm medical device manufacturers. Currently, only a fraction of the required uploads have occurred, creating potential compliance risks as the mandatory deadline approaches.
Just a year and four months after publishing a final rule that would have allowed it to regulate laboratory developed tests as medical devices, the US FDA has rescinded the controversial measure, finally putting an end to the saga.
At an Aug. 4 public meeting on MDUFA VI, FDA officials, industry representatives, and patient advocates outlined their priorities for the next user fee agreement, highlighting goals such as improved transparency, streamlined reviews, enhanced safety measures, and greater patient involvement.
Pending legislation seeks to address what the sponsors argue is a lack of transparency in medical billing. If enacted, the bill would provide patients with the costs of procedures and medications before receiving them. A data collection expert discusses what the bill could mean for patients.
NHS England's national chief clinical information officer issued a cease and desist on unapproved ambient voice technology and AI scribes. The move caused confusion among AVT vendors and went beyond joint MHRA/NHS guidance. IMed consultant Ben Austin shares his perspective.
The US House of Representatives passes legislation requiring manufacturers of non-flushable wet wipes to label products as ‘non-flushable," a move endorsed by the Personal Care Products Council.
Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.
The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.