How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals.

Abstract

Authors

• Eric Wu
  Department of Electrical Engineering, Stanford University, Stanford, CA, USA.
• Kevin Wu
  Department of Biomedical Data Science, Stanford University, Stanford, CA, USA.
• Roxana Daneshjou
  1Department of Biomedical Data Science, Stanford School of Medicine, Stanford, California, USA; email: roxanad@stanford.edu.
• David Ouyang
  Division of Artificial Intelligence, Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, California, USA.
• Daniel E Ho
  Stanford Law School, Stanford University, Stanford, CA, USA dho@law.stanford.edu.
• James Zou
  Department of Biomedical Data Science, Stanford University, Stanford, California.

Keywords

External Resources