North America

Dr. Oz, TV Personality And Cardiac Surgeon, Gets Nod To Head CMS

 
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Oz is widely seen as a gifted health communicator and has device-industry cred, but brings little experience running a large government organization or with the policy and budget challenges confronting Medicare and Medicaid.

Policy Leaders Press For More Medtech Support In Face Of Political Turmoil

 
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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.

Companies Will Face Increased Regulatory Challenges In 2025, Pair Of Reports Say

 

Medical device manufacturers are among the companies that will face more regulatory challenges in the coming year. Two new reports look at the growing complexity of the regulatory landscape organizations will have to navigate.


Kennedy's HHS Nomination Sparks Mixed Reactions in Medtech Sector

 
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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.

NEJM: US Firms Can’t Ignore EU AI Act

 
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Far-reaching AI regulations issued in the European Union also hold implications for US firms, a recent journal article claims. Companies that sell, use, import or distribute AI devices in the EU are all affected.

Staff Changes, New Leadership May Disrupt FDA Under Trump

 

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.

Some False Claims Act Enforcement May Cool Under Trump, Lawyers Predict

 
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Attorneys with law firm Gibson Dunn believe that fewer investors will be investigated for False Claims Act violations under the incoming Trump administration but expect other policy to go full steam ahead.


FDA Adds Devices To Breakthrough Program, Cardiology Devices Still Out Front

 

The US FDA has increased the number of devices cleared through its breakthrough program, which the agency established in 2015 to expedite access to products aimed at treating life-threatening and debilitating diseases.

Advisory Panel Recommends FDA Approve Marketing Authorization For Novel Breast Cancer Treatment

 

The US FDA’s advisory panel on general and plastic surgery devices voted in favor of agency approval for a novel medical device for treating early stage, low-risk breast cancer as a potential alternative to lumpectomy. The agency is expected to make its decision on the device early next year.

Cover Supplemental Breast Screenings, AdvaMed Urges Medicare

 

AdvaMed is calling on Medicare to provide coverage for supplemental screenings for women with dense breasts, an anatomical characteristic that puts them at a higher risk for cancer. The trade group says the lack of coverage for additional imaging results in many women not receiving potentially lifesaving follow-up.


Trump’s Victory Could Bring Kennedy ‘Wild’ Card To FDA

 

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.

Seasoned Advocate To Head FDA's Rare Disease Hub

 

Former Food and Drug Law Institute CEO Amy Comstock Rick will take on patient engagement for the US FDA Rare Disease Hub as director of strategic coalitions.

FDA Advisory Committee Focuses On Improving Informed Consent For Patients Volunteering For Device Trials

 

The US FDA’s Patient Engagement Advisory Committee met Wednesday to discuss ways the agency can empower patients thinking about whether to participate in clinical trials of regulated medical products. Central to the committee’s discussion was not only the type of information patients need to evaluate when considering joining a study, but how that information should be presented to them.

FDA Updates Cybersecurity Page With New Publications For Cybersecurity Awareness Month

 

Recognizing October as cybersecurity awareness month, the US FDA has added new publications to its list of resources concerning the cybersecurity of medical devices.


News We’re Watching: Medtronic and Hologic Safety Actions, $110M For Women’s Health, Brain Cancer CDx Approved

 

This week, Medtronic and Hologic announced major safety issues; the US government awarded $110m to innovators in women’s health; CDC partnered with Quest on a bird flu diagnostic; and more.

Opinion: The Fog at CDRH Is Lifting (a Bit)

 
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When former FDAer Steve Silverman last wrote for us, there was no formal successor to Jeff Shuren as director of CDRH. With the elevation of acting director Michelle Tarver, the future is becoming more clear.

FDA Drops Final Guidance On Safety Considerations For Neonatal Medical Products

 

The US FDA has published a final guidance document providing stakeholders with a framework for various safety evaluations they should consider when developing medical products for newborns, including devices. The guidance focuses on long-term evaluations of neurodevelopmental safety.

GOP Wants Check-In On FDA’s Lab Safety Issues

 
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House Republicans say the FDA has not done enough to support its laboratory safety office, despite past recommendations.