"As 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 essential part of an increasing number of medical devices. One of the greatest potential benefits of ML resides in its ability to create new and essential insights from the vast amount of data generated during the delivery of health care every day.
Interest in medical devices incorporating ML functionality has increased in recent years. Over the past decade, the FDA has reviewed and authorized a growing number of devices legally marketed (via 510(k) clearance, granted De Novo request, or approved PMA) with ML across many fields of medicine—and expects this trend to continue.
The FDA is providing this list 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. Contents of this list: This list contains publicly available information on AI/ML-enabled devices. The FDA assembled this list by searching FDA’s publicly-facing information, as well as by reviewing information in the publicly available resources cited below and in other publicly available materials published by the specific manufacturers. This list is not meant to be an exhaustive or comprehensive resource of AI/ML-enabled medical devices. Rather, it is a list of AI/ML-enabled devices across medical disciplines, based on publicly available information."
In the face of the rising AI craze, people are addressing severe technical and ethical challenges that range from data scarcity to racial bias. As these challenges are tackled, the potential of AI can be realized, making healthcare more accurate, efficient, and accessible for patients worldwide.KB Medical Group Inc. will continue to monitor the landscape of medical devices integrating artificial intelligence and impending FDA regulations, along with the true implications of AI technological advancements for healthcare and business, as your leading global partner in the fields of safety parenteral nutrition support, enteral nutrition solutions, and preanalytical specimen collection systems, as well as in the realm of safety medical device research. With our fervor for innovation, utilization of state-of-the-art manufacturing technology, and robust supply capabilities, combined with nearly 40 years of experience in the healthcare sector, we are steadfast in our commitment to developing high-performance solutions that yield consistent and reproducible results upon which you can always rely. (The images following, generated by AI from KB Medical Group Inc., are for demonstration purposes ONLY, and they may differ from the actual objects.)
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