The U.S. Food and Drug Administration has announced the availability of its final guidance on AI medical devices. The document – Marketing Submission Recommendations for a Predetermined Change Control ...
The FDA recently had a meeting to explore regulatory aspects of AI-enabled mental health medical devices. I explore a useful ...
In response to a growing number of cyberattacks in the healthcare and life sciences industries, on Sept. 27, 2023, the U.S. Food and Drug Administration (FDA) released updated guidance regarding ...
ARLINGTON, Va.--(BUSINESS WIRE)--The Medical Device Innovation Consortium (MDIC) announces Pamela Goldberg, MBA, as President and Chief Executive Officer of MDIC effective today. Ms. Goldberg joins ...
FORT DETRICK, Md. -- Sustainment experts at U.S. Army Medical Logistics Command have developed new maintenance handbooks aimed at improving resource management practices and overall readiness for ...
CyberActa medical device software design and development expertise minimizes vulnerabilities and reduces attack surface of every phase of the development cycle ...
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 ...
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