FDA Lists More Than 1,500 AI-Enabled Medical Devices as Oncology Applications Expand
oncodaily - The U.S. Food and Drug Administration (FDA) has listed more than 1,500 artificial intelligence-enabled medical devices authorized for marketing in the United States, reflecting the growing integration of AI across […]
AI Summary: The FDA catalogued more than 1,500 AI‑enabled medical devices, spurring criticism that most were cleared without direct evidence they improve patient outcomes. Regulators and clinicians face mounting calls for post‑market studies and transparency, balancing enthusiasm for AI innovation against the sober question: do these devices actually help patients?
Ultragenyx Gene Therapy Becomes First FDA-Approved Treatment for Ultra-Rare Disease
Frank Vinluan / medcitynews - Ultragenyx Pharmaceutical’s Genglycos received accelerated FDA approval for glycogen storage disease type Ia, an inherited enzyme deficiency. It’s also the first approved gene therapy for Ultragenyx, which specializes in rare disease treatments. The post …
AI Summary: Ultragenyx received FDA approval for a gene therapy, marking the first approved treatment for that particular ultra‑rare disorder. The decision provides a regulated therapeutic option for patients previously without approved care, highlighting the evolving regulatory willingness to greenlight transformative but small‑population medicines.