Breast cancer detection system receives marketing approval from FDA.

2003 DEC 4 - (NewsRx.com & NewsRx.net) -- iCAD, Inc., (ICAD) has received necessary approval from the U.S. Food and Drug Administration (FDA) to market its new iCAD iQ Computer Aided Detection system.

The iQ system is designed specifically for women's health centers and breast clinics that perform less than 20 mammography procedures per day. Shipment of the iQ system is scheduled to begin within the fourth quarter of 2003, and the company is now accepting orders for the new product.

"Mammography centers that perform less than 20 mammogram readings per day account for one third to one half of the market, and they have been priced out of the market until now," commented W. Scott Parr, president and chief executive officer of iCAD, Inc.

"Our ability to provide an affordable computer aided detection product with the same clinical efficacy as our highly rated MammoReader CAD solution creates an excellent opportunity to significantly expand this underserved market while improving the access of millions of women to the benefits of earlier breast cancer detection."

The FDA approval also permits use of the company's new Fulcrum digitizer in connection with its highly rated MammoReader computer aided detection products. According to Parr, this will permit iCAD to expand its product offerings in the area of networked CAD, in which satellite mammography screening and film scanning points are networked and connected in a "hub and spoke" configuration using the iCAD MammoReader's central CAD database.

iCAD believes its new iQ product is a category-defining CAD system. With pricing 30% to 50% less than currently available CAD products, the company has designed the iCAD iQ to be the first product on the market to allow lower-volume clinics to provide CAD services to women on a cost-effective basis.

The iQ is simple to operate and self-training in nature, has been designed to fit within the limited space requirements of smaller mammography clinics, and will be offered for a purchase price of less than $70,000.