Confirma debuts next version of CADstream introducing innovative interventional guidance tool

Kirkland 08 July 2004Confirma Inc., specialized in computer-aided-detection (CAD) for MRI, has introduced CADstream 3.1, offering imaging centres, for the first time ever, a CAD-analysis tool, SureLoc, for more convenient and efficient magnetic resonance imaging (MRI)-guided interventional procedures. A 2003 study published in Radiology reported that up to 14 percent of malignant lesions in the breast are detectable only by MRI, according to Elizabeth A. Morris, MD, et al., "Breast Lesions Detected with MR Imaging: Utility and Histopathologic Importance of Identification with US", Radiology 2003; 11:856-861.


Confirma received 510(k) clearance from the FDA for CADstream 3.1, on July 7, 2004. Using CADstream and SureLoc, physicians can now calculate co-ordinates or targets for MR-guided interventions using a breast coil at the point-of-procedure. CADstream 3.1 incorporates additional new and improved features, including optimized remote-viewing performance, allowing MRI studies to be read anywhere within a high-speed network and a 2D AutoROI feature, which identifies uptake and washout characteristics within a user-defined 2D region of interest, or image-slice.

"SureLoc is a valuable addition to our breast MR programme and, as a Beta site for CADstream 3.1, we have already seen this tool significantly impact our lesion localization procedure process", stated Kara Carlson, MD, Medical Director, Evergreen Breast Center, Kirkland, Washington. "Since integrating CADstream into our breast centre in Spring 2003, our ability to provide improved analysis of breast MRI studies has dramatically increased. Now, with SureLoc we have a complete CAD breast MR analysis package. The SureLoc results from CADstream have eliminated the need for any manual calculations and have increased our biopsy efficiency."

CADstream technology enhances efficiency and work flow for MRI studies by automating data analysis, improving image management and correcting for patient movement, which assists radiologists in the interpretation and analysis of these data-intensive studies. CADstream's automated features include image registration, subtractions, angiogenesis maps, interactive real-time contrast curves, multiplanar reformatting, maximum intensity projections (MIPs) and volume summaries.

The new and expanded features of CADstream 3.1 include:

  • SureLoc, designed for users currently performing MR-guided interventional breast procedures. This enables automatic CAD-analysis and reporting of lesion location and calculations at the point of procedure.
  • Optimized remote-viewing capability allows for an improved remote connection between CADstream and CADalyst, CADstream's network-based user-interface.
  • 2D AutoROI automatically finds the curve with the most worrisome uptake and washout characteristics within a user-defined 2D region of interest.

MRI is a non-invasive imaging procedure that uses magnets and radio waves to visualize the inside of the body. In addition to being accurate and highly sensitive, MRI does not carry the inherent risks of radiation or invasive imaging procedures. The capacity of MRI to deliver high-quality images often eliminates the need for more expensive and invasive procedures.

Breast MRI is primarily used for determining extent of disease or staging, monitoring response to therapy in breast cancer patients and screening patients at high risk for breast cancer. Approximately 8,5 million women in the United States are at high risk for developing breast cancer. Since 1999, there has been a 40 percent per year increase in the number of MRI studies performed in the United States. In May 2003, the American Cancer Society released updated guidelines on breast cancer screening, recommending MRI as an effective and sensitive imaging adjunct to mammography.

Approximately 1,47 million women will undergo breast biopsy in 2004, according to the "US Breast Cancer and Gynaecologic Oncology Markets" study, IHS(R) Health Group 2003; 6:#RP-191297. An MR-guided biopsy of the breast is a minimally invasive procedure that establishes a precise diagnosis of a breast problem without the need for a surgical biopsy. MRI is utilized to localize the abnormality if not seen mammographically, or with ultrasound.

The procedure allows the surgeon to remove a small amount of breast tissue for the pathologist to make a definitive diagnosis. In the case of a breast MRI-guided intervention using wire localization, a small needle containing a wire is inserted into the suspicious area after local anaesthesia is administered. After the location of the needle is verified by additional MR imaging, the needle is removed, leaving the wire in place in order to guide the breast surgeon to the abnormality during surgery.

Confirma's product, CADstream, is the first CAD system designed specifically for MRI. CADstream provides higher quality imaging studies, lower costs for radiology practices and improved communication tools for physicians and patients. Confirma was recently awarded the 2003 Entrepreneurial Company Award by Frost & Sullivan for its innovative CAD technology.

Leslie Versweyveld

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