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.
The EU’s PRRC role can differ substantially according to the circumstances at individual companies. But there is a need to further understand and shape PRRC's responsibilities so there is strong consistency across the board, PRRCs and associated stakeholders heard recently in Malaga.
Medtech engineering association shares concerns over regulations, innovation and EU competitiveness with remainder of medtech industry.
The EU medtech regulations are being targeted for change, with many amendments being critical for the sector and patients. Ireland’s Niall MacAleenan explained why tackling governance is the most critical part of this at a recent meeting in Galway.
Behind the scenes, there were many conflicting, but also useful discussions, which ultimately shaped the message the European Parliament delivered to the European Commission in late October about the need for changes to the Medical Device and IVD Regulations.
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.
In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb talks about her interview with GE HealthCare’s chief AI officer Parminder Bhatia about his vision for AI in health care and other highlights from HLTH. Natasha Barrow discusses her interview with Owkin on the EU AI Act and highlights Click Therapeutics’ latest clinical results.
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.
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 milestones on MHRA’s in-progress medtech regulatory roadmap for Great Britain will be subject to some change in the coming months.
The European Commission has issued a draft document setting out the potential conditions for joint HTA scientific consultations on medical devices taking place in parallel with consultations with an expert panel.
Device supply interruptions and withdrawals, now common in the EU, could threaten patient safety. Newly issued manufacturer guidance from the European Commission is intended to improve transparency and minimize disruption.
European cross-country HTA collaborations have much to learn from each other to keep prices from rising unfairly, Nordic health technology assessment experts say, adding that talks on collaboration are also ongoing with HTA bodies outside the continent.
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.
House Republicans say the FDA has not done enough to support its laboratory safety office, despite past recommendations.
An agreement between the EU and Switzerland potentially opening the way for renewal of the MRA – enabling barrier-free cross-border medtech trade – could be concluded as early as December. More good news for Switzerland, relating to the acceptance of FDA-approved products into the country, could follow in Q1 2025.
The European Parliament wants the European Commission to revise the Medical Device Regulation within 100 days. But EU member state authorities warn of the consequences of rushing matters.