The proposed rule from the US HHS that would require its agencies to review all regulations every 10 years could distract an incoming Biden administration from the COVID-19 pandemic and will “wreak havoc” on Medicare, a senior policy analyst for the Center on Budget and Policy Priorities says.
A proposed rule released last month by the US Department of Health and Human Services is the Trump administration’s “latest attempt to sabotage HHS programs,” a policy expert says.
Under the 4 November draft rule – Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) – the HHS would...
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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.
