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Notification of a Voluntary Product Recall for Software Used in a Prior Published Article

Notification of a Voluntary Product Recall for Software Used in a Prior Published Article Published March 11, 2021 as 10.3174/ajnr.A7063 LETTERS Notification of a Voluntary Product Recall for Software Used in a Prior Published Article n December 14, 2020, a voluntary product recall was adding 13 additional healthy brains to the 218 already in the data Oissued for the Neuroreader Medical Image Processing base. Furthermore, only the results of our secondary outcome Software that we utilized in our article “Improved Detection of could be affected. Nevertheless, we felt obligated to immediately Subtle Mesial Temporal Sclerosis: Validation of a Commer- inform the editorial staff of the AJNR and your readers of this cially Available Software for Automated Segmentation of unfortunate event. The latest version of the Neuroreader software Hippocampal Volume,” published in the March 2019 issue of has corrected this flaw. AJNR. The recall was issued because the normative data base used for demographic correction of the postprocessed volumes REFERENCE was produced from MRIs performed on 218 healthy patients, 1. Mettenburg JM, Branstetter BF, Wiley C, et al. Improved detec- instead of the 231 MRIs expected by the FDA. This normative tion of subtle mesial temporal sclerosis: validation of a com- data base was used to calculate the proprietary Neuroreader mercially available software for automated segmentation of Index that we reported as a secondary outcome in our research. hippocampal volume. AJNR Am J Neuroradiol 2019;40:440–45 CrossRef Medline The normative data did not affect our main outcome variable of segmented hippocampal volume as a percentage of intracranial J.M. Mettenburg volume. Department of Radiology We believe that the results of our research are still valid, as University of Pittsburgh School of Medicine only small changes in normative values would be expected when Pittsburgh, Pennsylvania http://dx.doi.org/10.3174/ajnr.A7063 AJNR Am J Neuroradiol : 2021 www.ajnr.org 1 Copyright 2021 by American Society of Neuroradiology. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png American Journal of Neuroradiology American Journal of Neuroradiology

Notification of a Voluntary Product Recall for Software Used in a Prior Published Article

American Journal of Neuroradiology , Volume Publication Preview – Mar 11, 2021

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Publisher
American Journal of Neuroradiology
Copyright
© 2021 by American Journal of Neuroradiology
ISSN
0195-6108
eISSN
1936-959X
DOI
10.3174/ajnr.A7063
Publisher site
See Article on Publisher Site

Abstract

Published March 11, 2021 as 10.3174/ajnr.A7063 LETTERS Notification of a Voluntary Product Recall for Software Used in a Prior Published Article n December 14, 2020, a voluntary product recall was adding 13 additional healthy brains to the 218 already in the data Oissued for the Neuroreader Medical Image Processing base. Furthermore, only the results of our secondary outcome Software that we utilized in our article “Improved Detection of could be affected. Nevertheless, we felt obligated to immediately Subtle Mesial Temporal Sclerosis: Validation of a Commer- inform the editorial staff of the AJNR and your readers of this cially Available Software for Automated Segmentation of unfortunate event. The latest version of the Neuroreader software Hippocampal Volume,” published in the March 2019 issue of has corrected this flaw. AJNR. The recall was issued because the normative data base used for demographic correction of the postprocessed volumes REFERENCE was produced from MRIs performed on 218 healthy patients, 1. Mettenburg JM, Branstetter BF, Wiley C, et al. Improved detec- instead of the 231 MRIs expected by the FDA. This normative tion of subtle mesial temporal sclerosis: validation of a com- data base was used to calculate the proprietary Neuroreader mercially available software for automated segmentation of Index that we reported as a secondary outcome in our research. hippocampal volume. AJNR Am J Neuroradiol 2019;40:440–45 CrossRef Medline The normative data did not affect our main outcome variable of segmented hippocampal volume as a percentage of intracranial J.M. Mettenburg volume. Department of Radiology We believe that the results of our research are still valid, as University of Pittsburgh School of Medicine only small changes in normative values would be expected when Pittsburgh, Pennsylvania http://dx.doi.org/10.3174/ajnr.A7063 AJNR Am J Neuroradiol : 2021 www.ajnr.org 1 Copyright 2021 by American Society of Neuroradiology.

Journal

American Journal of NeuroradiologyAmerican Journal of Neuroradiology

Published: Mar 11, 2021

References

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