How the FDA Regulates AI

Author:

Harvey H. BenjaminORCID,Gowda Vrushab

Publisher

Elsevier BV

Subject

Radiology, Nuclear Medicine and imaging

Reference30 articles.

1. Artificial intelligence is the stethoscope of the 21st century. Available at: https://medicalfuturist.com/ibm-watson-is-the-stethoscope-of-the-21st-century. Accessed on July 25, 2019.

2. Pivotal trial of an autonomous AI-based diagnostic system for detection of diabetic retinopathy in primary care offices;Abràmoff;NPJ Digit Med,2018

3. Statement from FDA Commissioner Scott Gottlieb, M.D. on steps toward a new, tailored review framework for artificial intelligence-based medical devices. Available at:https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-steps-toward-new-tailored-review-framework-artificial. Accessed on July 25, 2019.

4. Concepts in U.S. food and drug administration regulation of artificial intelligence for medical imaging;Kohli;AJR Am J Roentgenol,2019

5. FDA approvals for smart algorithms in medicine in one giant infographic. Available at: https://medicalfuturist.com/fda-approvals-for-algorithms-in-medicine. Accessed on July 25, 2019.

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