The U.S. Food and Drug Administration has announced the availability of its final guidance on AI medical devices. The document – Marketing Submission Recommendations for a Predetermined Change Control ...

Forbes contributors publish independent expert analyses and insights. Dr. Lance B. Eliot is a world-renowned AI scientist and consultant. In today’s column, I examine the recently published FDA ...

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has advanced its effort to set up a post-Brexit regulatory environment by initiating a consultation on medical device regulation and ...

AI is evolving healthcare. While it's a powerful tool to support everything from automation to predictive analysis, it also brings about pause for its inherent risks. Simply put, AI is a cybersecurity ...

Small-scale wireless soft robotics can be designed as implantable, interventional or wearable devices for various biomedical applications. Their flexibility, dexterity, adaptability and safe ...

In the document, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning-Enabled Device Software Functions," the FDA proposes to ...