The advantages of CAD are now available for breast ultrasound thanks to a new product from Cedara Software Corp., a division of Merge Technologies Inc. Cedara yesterday announced that its Cedara B-CAD, the first computer aided detection (CAD) solution for breast ultrasound, has received 510(k) clearance from FDA. Cedara B-CAD will soon be commercially available in the United States.
B-CAD was developed by Toronto based Medipattern Corp., a company focused on medical pattern recognition and brought to market by Cedara Software Corp. through its Technology Partnership Program. Cedara B-CAD marks a strong advance for the fight against breast cancer.
As a workflow tool, B-CAD assists radiologists in the analysis of breast ultrasound images through automated segmentation, characterization, classification, annotation and report generation, Cedara said. Breast ultrasound is particularly useful to evaluate palpable masses in young (under the age of 30), pregnant, and lactating women, among others.
"Today's acid test for malignancy in breast cancer is the core biopsy," said Jennie Sharpe, clinical specialist at Cedara Software. "This is an invasive procedure that can be particularly traumatic for women already concerned about their health. This said, statistics show that approximately 50 percent of biopsies ordered are benign. It is our hope that further improvements to diagnostic imaging will help radiologists assess the need to biopsy a selected nodule."
B-CAD automatically analyzes, segments, and classifies shape and orientation characteristics of user-selected regions of interest (ROI), Cedara said. B-CAD includes the option to add annotations based on the Stavros criteria, as well as the ACR BI-RADSR Breast Imaging Atlas (American College of Radiology Breast Imaging and Reporting Data System). The report also has been designed to support compliance with the ACR BI-RADSR Ultrasound Lexicon Classification Form.
Due to the increasing utilization of breast ultrasound, the ACR recently developed the BI-RADS Ultrasound Lexicon for breast sonography to standardize the characterization of sonographic lesions. The original BI-RADS lexicon, which was developed for mammography, was quickly adopted by the Mammography Quality Standards Act (MQSA) and it is anticipated that the MQSA will adopt the new Ultrasound Lexicon as a standardized reporting format.
"This tool should facilitate acceptance and utilization of the ACR BI-RADSR Ultrasound Lexicon by radiologists as a standard upon which the foundation of CAD enabled ultrasound can be built," said A. Thomas Stavros, MD, of The Sally Jobe Breast Center in Denver, Colo., a pioneer in feature identification and classification of breast lesions in ultrasound. "Ultrasound CAD has many possible indications including assisting radiologists in analysis of solid breast nodules, which is a significant first milestone. This tool may improve a radiologist's interpretive confidence."
"Being first to market with a product like B-CAD reinforces the role Cedara can play in helping launch clinical application companies like Medipattern," said Chris Barlow, director of business development at Cedara. "With a strong presence in the medical imaging marketplace, Cedara can bring viability to start-up companies through assistance in software development, financing, marketing, sales and channel access."
Cedara B-CAD will be immediately available as a component that can be integrated into other organization's DICOM compliant Workstations and ultrasound machines, as well as a feature in Cedara's Breast Imaging Workstation, Cedara I-ReadMammoT.
In related news, Merge Technologies, Cedara and eMed Technologies announced this week the closing of the merger between Merge eFilm and Cedara Software, effective June 1st. Richard Linden is president and CEO of the combined company, and Abe Schwartz, Cedara president and CEO, continues as a member of the Merge eFilm Board of Directors.