Peter Elkin, chair of the Department of Biomedical Informatics in the Jacobs School of Medicine and Biomedical Sciences at UB, was invited to serve on the FDA's Digital Health Advisory Committee.
By using pre-determined change control plans, manufacturers can update AI-enabled devices without filing an additional FDA ...
Algorithms that help to analyze CT scans, MRIs, and X-rays account for more than three-quarters of AI-based devices ...
In a letter to the FDA, members of Congress cite confusion over providers' deployment of clinical decision support software that is exempt from medical device regulations and call for clarity from its ...
The potential number of use-cases for AI in healthcare settings seems to be increasing at an exponential pace. Moving beyond ...
Speaking to reporters after inaugurating the Second Kuwait Conference on Artificial Intelligence in Medicine and Robotic ...
A recent article authored by Haider J. Warraich, MD; Troy Tazbaz; and Robert M. Califf, MD in the Journal of the American ...
Neurosurgeons know brain cancer patients live longer and do better if they're able to remove the entire tumor. Now, there's an AI tool to help them.
FDA’s primary challenge in regulating AI-enabled device software functions (“AI-DSF”) has been that the self-modifying nature of these ...
has said it will launch a pilot programme in the coming weeks to see how it can evolve the regulation of artificial intelligence as a medical device (AIaMD) technology. The AI-Airlock regulatory ...
More than a third of women across 10 health care practices chose to enroll in a self-pay, artificial intelligence (AI)-enhanced breast cancer screening program, and the women who enrolled were 21% ...