Aurora receives 510(k) for increased field strength

AuntMinnie.com staff writers

Aug 6, 2003

Breast MRI developer Aurora Imaging Technology of North Andover, MA, has received Food and Drug Administration 510(k) marketing clearance for a new, 1.5-tesla version of its dedicated breast MRI scanner. The increase in field strength, from a 0.5-tesla to a 1.5-tesla system, will improve image resolution and is a precursor to the integration of Aurora’s proprietary fat-suppressed, high-resolution, high-contrast imaging technique (RODEO) developed by Dr. Steven Harms and Duane Flamig, according to the company.

By AuntMinnie.com staff writers
August 7, 2003
Related Reading

Aurora gets OK for interventional breast MRI, February 12, 2003

Aurora scores breast MRI install, November 28, 2002

Aurora reports MRI-guided breast biopsy, September 30, 2002

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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