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Smart & Biggar

Trends in patent filing for artificial intelligence-assisted medical technologies

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Medical technologies incorporating artificial intelligence (AI) are an emerging area of innovation with the potential to transform healthcare. Employing techniques such as machine learning, deep learning and natural language...more

McDermott Will & Schulte

FDA Issues Good Machine Learning Practice Guiding Principles

On October 27, 2021, pursuant to the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device Action Plan (Action Plan), the US Food and Drug Administration (FDA) released its Good Machine Learning...more

Nutter McClennen & Fish LLP

Code Red: The FDA’s Artificial Intelligence/Machine Learning Action Plan Poses Potential Risks for Medical Device Makers

Q: The FDA’s stance on a regulatory framework for artificial intelligence and machine learning (AI/ML) software as a medical device is continuously evolving. Could you explain the history? A: Artificial intelligence (AI) is...more

Akin Gump Strauss Hauer & Feld LLP

FDA Releases Action Plan for Artificial Intelligence/Machine Learning-Enabled Software as a Medical Device

Key Points - FDA will publish draft guidance on its Predetermined Change Control Plan in 2021 and host a public workshop on transparency requirements around AI/ML-based devices. - FDA plans to pilot Real-World Performance...more

McDermott Will & Schulte

FDA Issues Artificial Intelligence/Machine Learning Action Plan

On January 12, 2021, the US Food and Drug Administration (FDA) released its Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. The Action Plan outlines five actions that...more

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