IDSI PMA judged suitable for filing

AuntMinnie.com staff writers

Jun 17, 2003

CT laser mammography developer Imaging Diagnostic Systems has been notified by the Food and Drug Administration that an initial review of its pre-market approval (PMA) application for its CT breast imaging system has been judged to be suitable for filing. As such, the FDA will now conduct an in-depth evaluation of the safety and effectiveness of the device to determine final approval, according to the Fort Lauderdale, FL-based vendor.

By AuntMinnie.com staff writers
June 18, 2003
Related Reading

Imaging Diagnostic Systems receives 12th U.S. patent, May 29, 2003

Imaging Diagnostic Systems files PMA, April 30, 2003

Imaging Diagnostic Systems adds Berlin site, February 3, 2003

IMDS nets CTLM deal in Dubai, January 23, 2003

IDSI installs CTLM in Berlin, September 12, 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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Images in a 70-year-old asymptomatic woman with a prior excisional biopsy in the left breast yielding lobular carcinoma in situ 3 years earlier. Screening contrast-enhanced mammography (CEM) was performed, which was considered a prevalence screen as the woman had no prior breast MRI in the past 3 years and no prior CEM. (A) Low-energy (26–30 kVp) mediolateral oblique (MLO) and (B) craniocaudal (CC) views show surgical clips but no abnormality. (C) Recombined MLO and (D) CC images show an enhancing mass in the medial left breast (arrows). Biopsy revealed invasive lobular carcinoma. Size was 0.2 cm; tumor grade II/III; negative lymph nodes; and estrogen receptor–positive, progesterone receptor–positive, and human epidermal growth factor receptor 2–negative.

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