Category: FDA/Regulatory

Get to Know the DSO, Episode 2: Conducting a Validation Study as Part of a Regulatory Submission

November 21, 2022

FDA-Regulated AI Algorithms: Trends, Strengths, and Gaps of Validation Studies

Ebrahimian S, Kalra MK, Agarwal S, Bizzo BC, Elkholy M, Wald C, Allen B, Dreyer KJ.

Acad Radiol. 2021 Dec 27:S1076-6332(21)00415-3. doi: 10.1016/j.acra.2021.09.002. Epub ahead of print. PMID: 34969610

December 27, 2021

The Standardized Exposure Index for Digital Radiography: An Opportunity for Optimization of Radiation Dose to the Pediatric Population

Ng KH, Wong JHD, Clarke GD, Allisy-Roberts P, Williams J, Burgess AE, Bushberg JT, Seibert JA, Leidholdt EMJ, Boone JM, Dance DR, Christofides S, Maidment ADA, McLean ID, Dendy PP, Heaton B, Tan SK, Borras C, Norweck JT, Andriole KP, et al.

Problems and Solutions in Medical Physics. 2018; 16:1-7

April 14, 2011