AI regulation

 A 101 on the new FDA guidance for the approval of quantitative radiological products July 26, 2022 by Floor van Leeuwen In June 2022, the Food and Drug Administration (FDA) published a Guidance document1 to serve manufacturers of radiological devices as guidance when ... Read Post
Regulatory approval of medical devices for COVID-19 April 09, 2020 by Floor van Leeuwen For newly developed medical devices to be able to make a difference in the current COVID-19 pandemic, development and regulatory approval needs to be ... Read Post
A 101 guide to the FDA regulatory process for AI radiology software November 20, 2019 by Floor van Leeuwen During 2019, many AI healthcare companies announced FDA clearance for their medical device - this often considers AI radiology software. What does it ... Read Post
AI medical software: how will the FDA deal with it? April 09, 2019 by Arnault Massink Last week, the FDA announced that they will be investigating a new review framework for artificial intelligence (AI) based medical devices.1 Over the ... Read Post
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