In the document, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning-Enabled Device Software Functions," the FDA proposes to ...
The Food and Drug Administration (FDA) has released guidance providing recommendations on what information should be included in a predetermined change control plan (PCCP) tailored to marketing ...
The FDA has quietly authorized more than 1,000 medical devices incorporating artificial intelligence or machine learning, marking a significant growth of AI in healthcare. The agency’s AI/ML-Enabled ...
The U.S. Food and Drug Administration (FDA) is seeking comments on methods of assessing the real-world performance of AI-enabled medical devices, including generative AI. Prior FDA draft guidance has ...
Katie Palmer covers telehealth, clinical artificial intelligence, and the health data economy — with an emphasis on the impacts of digital health care for patients, providers, and businesses. You can ...
According to the Food and Drug Administration (FDA), the traditional paradigm of medical device regulation was not designed for adaptive artificial intelligence and machine learning technologies. As a ...
The Advanced Research Projects Agency for Health (ARPA-H) is soliciting proposals to develop two agentic AI assistants for ...
What has been filed over the years? The number of patents filed in each subcategory of AI-assisted applications for medical technologies from 2001 to 2023 is shown below. Let’s look at the annual ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results