On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance ...
Cybersecurity has evolved from a secondary software concern to a core design requirement in connected medical devices. The rapid growth of the internet of medical things (IoMT) has expanded the attack ...
The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations ...