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Healthcare › Manufacturers › Software

Ballard Spahr LLP

FDA Issues Guidance on AI for Medical Devices

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The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 10, December 2024

Spilman Thomas & Battle, PLLC on

Happy Holidays and welcome to our year-end issue of Decoded. We hope you enjoyed reading our technology law insights e-newsletter this year. We are already planning for 2025. ...more

Knobbe Martens

AI & the FDA

Knobbe Martens on

The use of artificial intelligence (AI) in healthcare has been growing rapidly in recent years, and AI-enabled medical devices are playing a larger role in patient care. Such devices may use machine learning algorithms to...more

Hogan Lovells

Obama Administration Issues Changes to Iran Sanctions Regulations That Benefit Exporters of Medicine, Medical Devices and...

Hogan Lovells on

On December 23, 2016, the U.S. Treasury Department’s Office of Foreign Assets Control (“OFAC”) published a number of changes to the Iranian Transactions and Sanctions Regulations (“ITSR,” 31 C.F.R. Part 560) that expanded the...more

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