The U.S. Food and Drug Administration (FDA) is building HALO (Harmonized AI and Lifecycle Operations for Data), a secure, AI-ready enterprise data platform on Databricks for Government, which runs on …
The U.S. Food and Drug Administration (FDA) has released a new discussion paper on generative AI devices, signaling forthcoming guidance for the technology. The announcement was made at Epic's Users G…
The U.S. Food and Drug Administration (FDA) does not mandate a universal sample size for sensitivity and specificity studies, but its final 2025 guidance for AI-enabled device Predetermined Change Con…
On May 29, 2026, Johns Hopkins University researchers and U.S. Food and Drug Administration collaborators published G-AUDIT, a modality-agnostic framework for auditing medical AI datasets for bias, in…
404 Media reported that an AI-powered TikTok Shop operation produced and sold dietary supplements that the U.S. Food and Drug Administration (FDA) recalled, highlighting the risks of AI-generated cont…
Insilico Medicine announced on July 29 that the U.S. FDA granted Fast Track Designation to its AI-designed pan-TEAD inhibitor ISM6331 for adults with unresectable malignant pleural mesothelioma after …
United Imaging Intelligence, the AI subsidiary of Chinese medical technology giant Shanghai United Imaging Healthcare, is deliberately slowing its AI deployment in healthcare, resisting a national pus…
Stanford Medicine treated its first proton therapy patient, 7-year-old Stephen De La Torre, using a new compact particle accelerator developed by Mevion Medical Systems. The device, approved by the FD…
Arrival of the "agentic era," where organizations are moving beyond AI pilots to real-world, scalable impact using AI agents. It highlights how leaders at the U.S. Department of Transportation, the FD…
Here is a factual summary of the article: Scientists at the University of Toronto have developed a new generation of CAR T-cells that multiply and remain active for longer periods, showing greater ef…