The FDA has launched a pilot program called TEMPO that allows makers of generative-AI-enabled medical devices, including Cadence and Limbic, to bring products to market without full marketing authorization. The initiative is designed to expand technology options available through Medicare’s ACCESS model for chronic disease management. Regulators say the program gives both agencies and manufacturers hands-on experience with the technology in real-world settings, information they intend to use to shape future AI medical-device regulation.
