FDA approved Indications for Use:

 

"Breast Companion^® is a computer-aided system (CADx) intended for improving the ACR BI-RADS^® assessment of ultrasound images of lesions of the female breast as part of the diagnostic workup"

 

The American College of Radiology (ACR) developed the Breast Imaging Reporting and Data System (BI-RADS) program to guide interpretation and reporting of breast ultrasound exams. The ACR also manages a program to accredit the clinical practice of breast ultrasound. Similarly, in 1998 the American Institute of Ultrasound in Medicine launched a program to accredit the breast ultrasound practices of radiologists and sonographers. These steps by professional organizations are designed to improve the quality and uniformity of care. Acceptance and utilization of BI-RADS for ultrasound is increasing but the research literature, including our own reports, shows it is difficult to uniformly apply the method and there is considerable variability of lesion description and assessment between radiologists. Currently, breast biopsy serves as the key diagnostic tool in the evaluation of breast masses for malignancy. Unfortunately, breast biopsy is neither a benign nor an inexpensive process. Besides affecting patients physically and emotionally, the procedure frequently causes internal scarring, which obscures the results of future mammograms. Until fairly recently, ultrasound in the U.S. has been used only to distinguish cystic from solid breast masses and to guide needle biopsies. A number of positive studies in Europe, Asia and the U.S. indicate that high-quality ultrasound can provide radiologists with a high degree of confidence in differentiating many benign from malignant or suspicious lesions detected by mammography.

Almen Laboratories has developed and marketed sophisticated general application image-processing software products for imaging applications that provides extensive tools to identify objects and image features of interest, analyze the information content and then store, retrieve and compare different objects in images of interest based on this information. During the last 11 years, in collaboration with the University of California, San Diego (UCSD) School of Medicine and the Veterans Affairs Medical Center (VAMC) San Diego, parts of this software system were tailored to the needs of diagnostic breast ultrasound. The resulting breast assessment assisting software was created and validated under IRB-approved cohorts of cases with available confirmation of the “truth” via needle biopsy or 12-24 months follow-up for benign lesions.

The completed, validated and FDA approved product improves accuracy of practitioners, potentially  increasing their confidence in breast ultrasound, reduce variability of interpretations, and increase ultrasound’s role in breast cancer detection and management. The software automatically produces the radiologist created BI-RADS Report. More technical details can be found at the dedicated to these software systems web site at www.breastcompanion.com

 

This site is developed for the purpose of educating professionals and individuals in the developed Breast Ultrasound CADx technology and make FDA approved CADx software widely available for BI-RADS Assessment and Lexicon implementation based on the established and FDA approved reporting system (BI-RADS).