![]() Public-facing summaries are not all inclusive and do not include the majority of information that may be submitted in the full submission, which is often thousands if not tens of thousands of pages. Insights from this list: The insights regarding submission trends that are highlighted below were generated using both publicly available information provided in the summary descriptions of their marketing authorization document and certain aggregated information from internal sources. Rather, it is a list of medical devices that incorporate AI/ML across medical disciplines, primarily based on information provided in the summary descriptions of their marketing authorization document. This list is not meant to be an exhaustive or comprehensive resource of medical devices that incorporate AI/ML. The FDA compiled this list from the FDA’s publicly-facing information, including public-facing summaries and AI/ML specific product codes, as well as information in the publicly available resources cited below (*) and in other publicly available materials published by the specific manufacturers. The devices in this list have met the FDA’s applicable premarket requirements, including a focused review of the devices’ overall safety and effectiveness, which includes an evaluation of appropriate study diversity based on the device’s intended use and technological characteristics.Ĭontents of this list: This list contains publicly available information on AI/ML-enabled devices. The FDA is providing this list and insights of AI/ML-enabled medical devices marketed in the United States as a resource to the public about these devices and the FDA’s work in this area. As of October 19, 2023, no device has been authorized that uses generative AI or artificial general intelligence (AGI) or is powered by large language models. ![]() Over the past decade, the FDA has reviewed and authorized a growing number of devices (marketed via 510(k) clearance, granted De Novo request, or premarket approval) with AI/ML across many different fields of medicine-and expects this trend to continue. LLMs are AI models that are trained on very large datasets, enabling them to recognize, summarize, translate, predict, and generate content (for example: ChatGPT, Llama, Claude, PaLM, etc.). Interest in medical devices incorporating AI/ML functionality has increased in recent years and even more so in recent months due to the development of large language models (LLMs). Ensuring that these innovative devices are safe and effective, and that they can reach their full potential to help people, is central to the FDA's public health mission. Digital health technologies are playing an increasingly significant role in many facets of our health and daily lives, and AI/ML is powering important advancements in this field. One of the greatest potential benefits of AI/ML resides in its ability to create new and important insights from the vast amount of data generated during the delivery of health care every day. ![]() ![]() Of those newly added to the list, 155 are devices with final decision dates between August 1, 2022, and July 30, 2023, and 16 are devices from prior periods identified through a refinement of methods used to generate this list.Īs technology continues to advance every aspect of health care, software incorporating artificial intelligence (AI), and specifically the subset of AI known as machine learning (ML), has become an important part of an increasing number of medical devices. Octoupdate: 171 Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices were added to the list below. ![]()
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