CADx gets FDA approval for Second Look 6.0

AuntMinnie.com staff writers

Nov 12, 2003

Computer-aided detection (CAD) firm CADx Systems of BeaverCreek, OH, has received marketing approval from the U.S. Food and Drug Administration for its Second Look version 6.0 CAD software.

The application will be launched to the clinical community at the 2003 RSNA meeting this month in Chicago, CADx said.

By AuntMinnie.com staff writers
November 13, 2003
Related Reading

R2, CADx dismiss litigation, October 1, 2003

SourceOne switches CAD partners, September 12, 2003

CADx gets FDA nod for Second Look systems, August 13, 2003

GE expands CADx relationship, debuts Premium View, July 18, 2003

CADx signs accord with Premier, April 18, 2003

Copyright © 2003 AuntMinnie.com

(A) Free-response receiver operating characteristic (FROC) curve for DBT-DINO and DINOv2 (Meta AI) on the detection task. DINOv2 achieved higher sensitivity than DBT-DINO across most false-positive thresholds. (B) Detection rates of DBT-DINO and DINOv2 for lesions that were ultimately found to be benign (n = 70) and lesions that were found to be cancerous (n = 66). Error bars represent 95% CIs estimated via patient-level bootstrapping with 1000 repetitions. Both models showed similar detection rates for cancerous lesions, whereas DINOv2 detected more benign lesions than DBT-DINO. (C) Example bounding box predictions for DBT-DINO and DINOv2 on the detection test set. Each image is a single two-dimensional section from a three-dimensional digital breast tomosynthesis volume; the first column shows a mediolateral oblique view, and the second and third columns show craniocaudal views. Both models struggled to detect very small lesions, such as the 3-mm-diameter lesion shown in the first column. FP = false positive.

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