Despite proposals to alleviate the threat of medtech products being unnecessarily removed from the EU market when their old certificates expire, concerns remain at the highest level and calls for action persist.
Local reports indicate that the French government is today officially requesting the European Commission to postpone the 26 May, 2024 date by which all medical devices, even those that have made use of the transition period, must comply with the Medical Device Regulation.
While no official statement had been made by the French government as Medtech Insight went to press, industry association, MedTech...
A recent approval from the US FDA allowing Boston Scientific to broaden its labeling for its pulse field ablation system means more patients with one type of AFib will have access to a promising new treatment.
A revised annex to the original decision also outlines expert remuneration limits and introduces further changes.
Thena Capital, the first UK-based early-stage specialist medtech firm, has made its first investment since closing its £50m fund. Medtech Insight spoke with general partner Pamela Walker Geddes to gain insight into Thena Capital’s investment strategy.
Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it.
Thena Capital, the first UK-based early-stage specialist medtech firm, has made its first investment since closing its £50m fund. Medtech Insight spoke with general partner Pamela Walker Geddes to gain insight into Thena Capital’s investment strategy.
HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
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.
