Philips gets FDA clearance for breast density measurement tool

AuntMinnie.com staff writers

Dec 19, 2013

Philips Healthcare has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a spectral breast density measurement application for its MicroDose SI full-field digital mammography (FFDM) system.

According to the company, it is the first clearance of a spectral breast density measurement tool, through which adipose (fat) and glandular tissue can be differentiated to measure volumetric breast density.

The application measures the glandularity and thickness in each pixel of an image to calculate the total volume and volumetric percentage of glandular tissue in the breast, Philips said.

Once the calculations are completed, the examination is assigned a MicroDose density score that correlates with BI-RADS. The measurement is displayed on the review workstation in the DICOM tag of the acquired image and is exported for display in a DICOM structured report.

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(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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