FDA Issues AI Guidance for Wearables, Decision Support Tools Jan 7, 2026 | 2:15 pm The Food and Drug Administration (FDA) is rolling out two new guidance documents aimed at clarifying how the agency will oversee artificial intelligence (AI) in consumer-facing health technologies, according to FDA Commissioner Marty Makary. […]
FDA Launches ‘Elsa’ GenAI Tool Jun 3, 2025 | 3:46 pm The Food and Drug Administration (FDA) launched the first agency-wide generative artificial intelligence (GenAI) tool on Tuesday to streamline efficiency for employees ranging from scientific reviewers to investigators. […]