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Event Title Public Workshop - Evolving Role of Artificial Intelligence in Radiological Imaging February 25 - 26, 2020

The intent of this public workshop is to discuss emerging applications of Artificial Intelligence (AI) in radiological imaging including AI devices intended to automate the diagnostic radiology workflow as well as guided image acquisition.

Artificial intelligence (AI), including machine learning technologies, has the potential to transform healthcare by deriving new and important insights from the vast amount of data generated during the delivery of health care every day.

The potential for independent action by these devices to bypass human clinical review is an important factor in their benefit-risk profile, and it heightens expectations for the safety and effectiveness of these devices.

Clinical AI applications may assist the acquisition of standardized images independent of the operator, guiding both sonographers and non-experts in sonography, potentially including lay users, to acquire images with equivalent diagnostic quality.

The addition of such clinical AI applications and the potential for new users of these devices, similarly affect the benefit risk profiles for these devices and the expectations for the safety and effectiveness of these devices.

In this workshop, FDA is also seeking innovative and consistent ways to leverage existing methods and to develop new methods for validation of these AI-based algorithms and explore opportunities for stakeholder collaboration in these efforts.   During the workshop, we will be discussing specific topics outlined in the Agenda below.

(301) 718-0200, F: (301) 718-0679 The general sessions of the workshop will be webcasted and the link will be posted on the website after the workshop.  The following public workshop Agenda is current as of 2/11/2020 and subject to change.

All requests to make oral presentations must be received by January 10, 2020, 4 p.m. If selected for presentation, FDA will notify presenters by January, 24, 2020 and presentation materials must be emailed to by February 5, 2020 to present at the event.

FDA-2019-N-5592 by March 26, 2020.  Please refer to the instructions for submitting comments to the docket to ensure that your feedback is received.  Please be advised that as soon as a transcript is available, it will be posted in the Dockets and accessible at  For questions regarding workshop content please contact: Jennifer A.