The Federal Drug Administration’s current cybersecurity requirements are not appropriate for addressing and avoiding medical ...
The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device ...
On December 3, 2024, the US Food and Drug Administration (FDA) published final guidance titled, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence ...
The use of smartphones in healthcare is old news. Despite the decade-old trend, many challenges still exist with utilizing a patient’s smartphone, especially with optimizing both safety and patient ...
Trends for medical device manufacturers in 2026 include balancing sustainability costs, flexible automation, AI-driven ...
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