Two studies recently published in JAMA argue that a higher recall rate tied to 510(k) devices cleared based on also-recalled predicate devices help to demonstrate 510(k) safety concerns.
Research from a pair of recent studies suggests some medical devices cleared by the Food and Drug Administration through the agency’s 510(k) program could be putting patients at risk.
The authors of the two studies, both published on 10 January in the Journal of the American Medical Association (JAMA),...
Ahead of the 11 June UK spending review and its anticipated funding uplift for healthcare and life sciences, the MHRA announced an expansion of its digital expertise by creating a dedicated hub in Leeds, a renowned center of medtech excellence.
The EU’s Artificial Intelligence Act, which entered into force on 1 August 2024, is already facing turbulence.
Manufacturing shifts, financial planning, and supply chain changes are among the adjustments that medtech leaders are making to Trump-era tariffs. Medtech Insight’s review of first-quarter earnings calls reveals how firms are navigating the impact and uncertainty of evolving trade policies.
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.
