CAD System for Mammography Approved by Feds
The new SecondLook digital computer-aided detection (CAD) system from iCAD received marketing clearance from the Food and Drug Administration. The diagnostic tool will be bundled with Fujifilm Medical Systems’s Computed Radiography for Mammography (FCRm) system. iCAD published a press release describing the product approval.
iCAD reports that their SecondLook CAD system is the first CAD tool designed for use with CR that has both been approved and is available for marketing in the United States. The company develops an array of computer-aided detection solutions. iCAD notes that Fujifilm was well prepared for the FDA approval and is ready to commence marketing efforts immediately.
The FujiFilm FCRm system initially received marketing clearance in July 2006. With this product, the company aided in the transformation of over 500 mammography screening rooms. FCRm is, in fact, the most commonly employed digital technology tool.
Benefits of incorporating CAD technology with standard mammography systems include the opportunity for the system to identify potentially missed malignancies. Other benefits include directing the radiologist’s attention to areas of concern and, overall, improving the interpretation of mammography studies completed.
Previous studies published on HospitalBuyer detailed the benefits of incorporating CAD tools with mammography, including B-CAD during ultrasound breast assessment. A study originally published in the journal Radiology last summer notes benefits of CAD when evaluating contrast-enhanced MRI of breast tissue.
April 4, 2008 Related topics: Product Launches, Product Approval & Certification, Imaging, Diagnostic