Industry, health-care providers and FDA discussed major issues in using additive manufacturing for making anatomical models at the agency's headquarters last month. The findings will be presented in a white paper from the Radiological Society of North America to help FDA figure out how to regulate the technology.
Ensuring repeatability and accuracy in creating 3D-printed anatomical models to help guide surgery and other patient care is a crucial challenge ahead for clinicians, device-makers and third-party service suppliers.
That was a key takeaway from a workshop co-convened last month by US FDA and Radiological Society of North America...
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Simultaneous revisions of the EU’s AI, data and medtech rules offer opportunities for simplification and alignment but also risk confusion and competing priorities. With political tensions in the background, does all this portend further unwanted compromises or delays for medtech?
After years of delays - and even skepticism in Rome last month when officials hinted at its imminent debut - the long-awaited EUDAMED medical device database release has finally been confirmed
The European Commission’s Digital Omnibus Package promises to simplify EU complex digital compliance processes, but is it taking the EU in the right direction in its simplification efforts?
Abbott has initiated a medical device correction for about 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the US after internal testing detected a risk the device may produce inaccurate glucose readings.
Abbott has initiated a medical device correction for about 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the US after internal testing detected a risk the device may produce inaccurate glucose readings.
A recent study demonstrates that certain types of blood-based tests that screen for multiple cancers at once have the potential to flip the script on cancer diagnoses, including some of the deadliest types.
The European Commission seems to have heeded many of the medtech industry’s points regarding challenges with the implementation of the AI Act within the Digital Omnibus. But the usual EU hurdles must be crossed before the sector will know if these proposals will make it into law.
