Tazbaz was director of the FDA’s Digital Health Center of Excellence for two years, leading key policies on artificial ...
The FDA’s framework for AI regulation, while robust for premarket evaluation, would benefit from more specific mechanisms for continuous monitoring of AI performance in diverse real-world settings.
Pharma, biopharma, and medical device makers should watch out for these perennial problems, which include inadequate ...
The U.S. Food and Drug Administration (FDA) said on Thursday it had identified three cybersecurity risks associated with ...
In the EU, the AI Act has been approved, carrying significant implications for medical device, technology, and pharmaceutical firms. In the US, ...
NeuroPace, Inc. (NASDAQ:NPCE), a medical device company specializing in neurological disorders with a market capitalization of $439 million, has been making significant strides in the epilepsy ...
Health Canada published proposed amendments to the Food and Drug Regulations and Medical Devices Regulations to ...
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Six months “a very limited window” for medical device shortage flaggingBeta CEO Marcel Botha talks about the FDA’s plans for medical shortage notifications and how Trump’s policies may impact US ...
MDR Certification Strengthens Resyca’s Leadership in Soft Mist Drug-Device Combination Products ENSCHEDE, NL / ACCESS ...
FDA regulation of cosmetics and beauty products may change under the new administration. Here's what you need to know if that ...
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