The agency also will not expand the guidance categories that may be issued “for immediate implementation” without prior public comment, but more guidance documents could be issued in Q&A or bulleted formats, the agency said.
The US Food and Drug Administration is changing its guidance practices, but will not provide a detailed summary of public...
GE HealthCare launches bkActiv S series – part of the bkPortfolio family of Active Imaging systems.
In this in-depth interview with Medtech Insight, Pavan Choudary unpacks the implications of recent free trade agreements (FTAs) such as India’s with the UK, the potential fallout from new US tariffs on Indian device exports, and the pressing need for regulatory harmonization.
The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.
EU countermeasures against US tariffs suggest medtech categories exported to the EU could be targeted for tariffs. MedTech Europe and the German IVDs industry have stressed the negative effects this would have on patient care.
The new AI Precision Medicine platform supports the company’s flagship product, EvoLiver, which received US FDA breakthrough device designation in April.
Experts at the Prix Galien UK Forum discussed the future of mental health innovation, emphasizing the important roles of digital solutions, diagnostic biomarkers and community involvement.
With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.
