Policy & Regulation

Increased staffing would enable the commission's device unit to drive urgent regulatory changes more quickly, leading cardiologist Alan Fraser tells Galway meeting

The EU’s health nominee may not be as controversial as the recent US one, but the candidate being grilled has proved the least popular of the commissioner nominations with MEPs

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.

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.

Despite the growing risks cybersecurity poses to the US healthcare system, the Department of Health and Human Services continues to face challenges in meeting the threat, according to a report from the GAO. The new report also provides recommendations for the department to beef up its cyber defenses.

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.

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.

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.

This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.  

Philips has issued a recall of various Trilogy ventilators due to safety issues that may affect their ability to properly function. The US FDA has designated the recall class I, its most serious.

Smiths Medical has recalled scores of Bivona tracheostomy tubes due to a manufacturing defect that can result in disastrous consequences. The company reports multiple injuries, and one death, linked to the devices.

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.

This week, renal denervation systems from Medtronic and Recor won Medicare coverage; Boston Scientific bought cardiac-mapping firm Cortex; Veravas and Phanes Biotech teamed up on an Alzheimer’s diagnostic; and more.

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.

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.

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.

Despite questions surrounding the SEC rule, including disputes being litigated in the US Eighth Circuit, companies must prepare to meet the new climate disclosure requirements in addition to related mandates in California and abroad. Experts emphasize opportunities beyond compliance.

As the 6 May deadline to implement the FDA’s final rule on lab-developed tests approaches, attempts to stop the rule from taking effect are set to play out in court. A panel of experts discussed the potential impact of these legal efforts, should they be successful, at the Medtech Conference in Toronto.

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.