The FDA 's new guidance on the evaluation of gender-specific data in clinical studies with medical devices highlights the importance of including men and women in a representative way in trial samples. The analysis of gender-differentiated data makes it possible to identify possible variations in the efficacy and safety of medical devices, contributing to a more rigorous and inclusive evaluation.

The FDA has released a new document on the use of Artificial Intelligence (AI) in the life cycle of medical products, reinforcing the need for transparency, safety and regulatory compliance. The FDA has identified four priority areas: global collaboration to protect public health, support for regulatory innovation, development of standards and best practices, and continuous monitoring of AI performance. The guidelines address everything from algorithm evaluation and bias mitigation to the resilience and cybersecurity of AI-based medical products. This initiative reinforces the FDA's commitment to responsible innovation, ensuring that AI applied to health contributes to medical advances without compromising patient safety.