Tag: Artificial Intelligence

The FDA issues Artificial Intelligence and Machine Learning (AI/ML) Software as a Medical Device Action Plan

On 01/12/2021, the U.S. Food and Drug Administration (FDA) issued the “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan” from the Center for Devices and Radiological Health’s Digital Health Center of Excellence. The Action Plan is a direct response to stakeholder feedback to the April 2019 discussion paper, “Proposed Regulatory Framework […]

Public Workshop – Artificial Intelligence in Radiological Imaging

The U.S. Food and Drug Administration (FDA) announced a public workshop entitled “Evolving Role of Artificial Intelligence in Radiological Imaging,” will be held February 25-26, 2020. This workshop is an opportunity for stakeholders to provide feedback to the FDA on the following topics: Emerging applications of Artificial Intelligence (AI) in radiological imaging, including devices intended […]

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