MammoReader clears FDA

Intelligent Systems Software in Boca Raton, FL, announced Jan. 17 that the FDA had cleared its computer-aided detection (CAD) system, MammoReader. The product is designed to help in early detection of breast cancer by increasing the detection of subtle signs of cancer. The system is cleared for both screening and diagnostic use. Supporting the company's FDA application were clinical data from 327 cancer cases, which showed that breast cancer in 23% of the women diagnosed with the disease could have been discovered an average of 14 months earlier on screening mammograms, if MammoReader had been used, according to the company. MammoReader analyses are based on digitized mammograms. The systems, which will be marketed by Instrumentarium, will be priced at $99,500 and up.