After a long delay, the EU’s first harmonized standards under the MDR and IVDR are trickling through ̶ but the standards situation is still far from ideal.
The first publication in the Official Journal of the EU of references of harmonized standards in the context of the Medical Device Regulation took place on 19 July, and those in the context of the IVD Regulation, on 20 July. They were published by means of European Commission implementing decisions.
If a standard is harmonized, then it can be used by manufacturers to demonstrate compliance with the General Safety and...
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.
