Day: November 13, 2025

For years, randomized clinical trials (RCTs) have been the gold standard for drug approvals, but they often fall short of reflecting real-world clinical practice. Real-World Evidence (RWE), data generated during routine clinical use, is expected to address this deficiency. While the US Food and Drug Administration (FDA) has been actively incorporating RWE, a recent study … Read more

Artificial Intelligence (AI) offers unprecedented tools for diagnosis and treatment. However, a new cross-sectional study of nearly 1,000 FDA-approved AI-enabled medical devices reveals a troubling gap between regulatory approval and robust clinical evidence. Questions are raised about the reliability of these tools to perform safely and effectively for every patient, regardless of their background or … Read more