With the US Election Day just weeks away, policy experts representing the Democratic and Republican tickets spoke to AdvaMed 2016 attendees in Minneapolis about the presidential candidates' positions on the medical device excise tax.
The US Congress enacted a two-year suspension of the medical device excise tax at the tail end of 2015, but that act did not remove the issue from the top of the priority list for industry. Permanent repeal of the tax will be a focus for industry lobbyists next year when a new administration is in the White House.
In that context, Aneesh Chopra, former chief technology officer for the Obama administration, and Tommy Thompson, who was the HHS...
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.
The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.
During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.
Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.
The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
Researchers at Johns Hopkins have used a robotic system to autonomously perform a key part of gallbladder surgery without a surgeon's hand. Lead author Axel Krieger says it could take five to 10 years before an autonomous robotic system will reach human trials and expects regulatory hurdles.
