Artificial Intelligence-Enabled Medical Devices
The FDA provides an updated overview of AI-enabled medical devices that have received marketing authorization, now totaling roughly 1,450 products across radiology, cardiology, neurology and other clinical specialties. The resource underscores how the agency is tracking approvals and clarifies that generative AI devices have not yet been authorized, highlighting evolving regulatory standards for clinical AI.
About LOG Standards
LOG Standards provides an independent accreditation signal for AI models used in healthcare, helping hospitals, care networks, and AI companies bring clinical AI readiness and governance into clearer conversations.
Our AI Intelligence Briefing tracks the latest developments in AI safety, AI in medicine, mental health AI, clinical AI governance, and regulatory policy — keeping healthcare stakeholders informed about the rapidly evolving AI landscape.