The US FDA’s device center has unveiled a new public dataset designed to assist chemistry laboratories in ensuring the robustness of chemical characterization methods used to assess the biocompatibility of medical devices.
The Center for Devices and Radiological Health is offering a new dataset its director, Jeff Shuren, says is part of the center’s ongoing commitment to reduce the burden of premarket processes, while increasing the consistency and transparency of biocompatibility methods.
In the agency’s announcement, Shuren further states the new data “will allow analytical chemistry labs to determine their ability...
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.
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.
To succeed in medtech, investors must focus on patient outcomes. Gilde Healthcare says involving patients boosts product effectiveness, access and market success — making it a smart strategy in today’s strained healthcare systems.
MedTech Europe is ready to become involved and shape Europe’s Life Sciences Strategy and help drive regulatory simplification from the top to make the EU “the world’s most attractive place for life sciences by 2030.”
MedTech Europe is ready to become involved and shape Europe’s Life Sciences Strategy and help drive regulatory simplification from the top to make the EU “the world’s most attractive place for life sciences by 2030.”
The UK government’s blueprint to deliver an NHS "fit for the future" was released on July 3.
Former HHS-OIG attorney Rob DeConti emphasized the significance of data analytics and compliance in combating healthcare fraud, urging medical tech companies to adopt robust measures to prevent potential risks.
