BREAST ULTRASOUND COMPUTER-AIDED LESION ASSESSMENT BASED ON BI-RADS

Companion Suite^TM is a computer-aided non-diagnostic software tool designed to assist radiologists in analyzing breast ultrasound images in order to reduce unnecessary biopsies. The software allows the user to automatically or manually segment (outline) and classify shape, texture and density of lesion in question.

The software allows the user to annotate, tag, measure, and automatically save the processed lesions from practitioners' selected views out of the breast ultrasound test imaging sequence. Our tool automatically quantifies the segmented lesion, calculates computer-base BI-RADS^® score and then generates a report based on the image analysis process and the radiologist input. The output may be viewed and sent to standard film or paper printers or sent electronically to an Intranet's Local Area Networks or Internet Server. The software may retrieve archived reports from a web server or other storage media.

If ordered by the client the report will contain annotations by radiologist based on BI-RADS^® Breast Imaging reporting lexicon. In addition, the radiologist compiled report form has been designed to support compliance with the BI-RADS^® Ultrasound Lexicon Classification Form.

When interpreted by a professional practitioner, Companion Suite^TM or its Internet version, computerized CAD scoring results may be useful in boosting the practitioner's confidence in determining his/her biopsy threshold. Patient management decisions should not be made based on the results of computerized scoring and always delegate interpretation and diagnostic decisions to professional practitioners. The ultrasound template images produced by Companion Suite^TMshould not be used by themselves for diagnostic purposes.

Please note that American College of Radiology provides the following Disclaimers and Warranties regarding use of their BI-RADS^® Atlas and Lexicon:

ACR Disclaimer:

"The American College of Radiology (ACR) Breast Imaging Reporting and Data System Atlas (BI-RADS^®Atlas) is the product of a collaborative effort among members of various committees of the American College of Radiology with cooperation from the National Cancer Institute, the Centers for Disease Control and Prevention, the Food and Drug Administration, the American Medical Association, the American College of Surgeons, and the College of American Pathologists. Development of the ACR BI-RADS^® – Ultrasound and ACR BI-RADS^® – MRI were supported in part by the United States Public Health Service Office of Women's Health, Susan G. Komen Foundation, United States Army Breast Cancer Research Program and the National Cancer Institute.

All referring physicians and radiologists should be aware of the benefits and limitations of the application of imaging techniques. Imaging techniques classified as investigational by the FDA have not been considered in developing the BI-RADS^® Atlas; however, study of new equipment and applications should be encouraged. The ultimate decision regarding breast imaging procedures and treatment must be made by the referring physician and radiologist in light of all the circumstances presented in an individual examination."

ACR Warranty:

"Warranty limitations. (i) ACR BI-RADS® is provided on an "as is" basis, without warranties of any kind, either express or implied, including, but not limited to, warranties of title, or implied warranties of merchantability or fitness for a particular purpose; (ii) the use of ACR BI-RADS® is at your own risk; (iii) access to ACR BI-RADS® may be interrupted and may not be error free; (iv) neither the American College of Radiology nor anyone else involved in creating, producing, or delivering ACR BI-RADS® contained therein, shall be liable for any direct or indirect, incidental, special, consequential, or punitive damages arising out of your use or inability to use ACR BI-RADS®."