FDA Medical Device Regulation Over the Use of AI in Clinical Trials As FDA noted in the JAMA article, artificial intelligence and machine learning (AI/ML) have many potential uses in clinical ...
Beta CEO Marcel Botha talks about the FDA’s plans for medical shortage notifications and how Trump’s policies may impact US ...
President Donald Trump has swiftly announced a series of executive orders that could impact the medech industry.
In the EU, the AI Act has been approved, carrying significant implications for medical device, technology, and pharmaceutical firms. In the US, ...
In the final days of the Biden Administration, the United States Food and Drug Administration (FDA) issued final guidance on ...
2024 was a critical year for the FDA’s Center for Devices and Radiological Health and included a smooth transition in leadership, but it was not without controversy. The agency triggered not one but ...
Amid a deluge of executive actions, the Trump administration has directed federal health agencies to pause external ...
AI is touching every industry, and healthcare is no exception: the global market size for healthcare AI, which was valued at ...
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