MammoCAT Advanced Full Field Digital Mammography System

项目摘要 乳腺癌仍然是美国女性癌症相关死亡的主要原因。 乳房X光摄影是唯一被批准用于人群乳腺癌筛查的成本效益高的方法，但失败了 在许多女性中发现癌症，并对其他人造成太多不必要的召回。费舍尔成像 开发了专有的“缝隙扫描”技术，显著提高了对比度和图像质量 提高了今天的乳房X光照相的分辨率，降低了辐射剂量。我们的技术还消除了 需要痛苦的乳房按压。这些基本的改进将改善临床表现。 通过发现漏诊的癌症并减少不必要的治疗，同时提高患者对 乳房X光检查建议。该提案描述了该平台的开发和可行性 测试我们的第一个产品MammoCAT™DM，它将提供卓越的双视图乳房X光检查。 本产品被CMS和CMS规定为II类、510k设备和当前程序报销 私人付款人允许患者数量平均的机构在大约一年内偿还设备费用。一个 MammoCAT DM的主要功能将是升级到我们的第二个产品MammoCAT DBT，该产品 将允许从多个角度捕捉图像，使其具有数字乳房断层合成能力。

Project Summary Breast cancer remains a leading cause of cancer related death among women in the United States. Mammography, the only cost effective method approved for population screening of breast cancer, fails to find cancer in many women and causes too many unnecessary call backs on the rest. Fischer Imaging has developed proprietary “slot scanning” technology that significantly improves contrast and image resolution of today’s mammography and lowers the radiation dose. Our technology also removes the need for painful breast compression. These essential enhancements will improve clinical performance by finding missed cancers and reducing unnecessary treatment while increasing patient compliance with mammography recommendations. This proposal describes the development and feasibility bench testing of MammoCAT™ DM, our first product, which will provide superior two view mammography. This product is regulated as a Class II, 510k device and current procedure reimbursement by CMS and private payors allows a facility with an average patient volume to pay off the device in about a year. A key feature of MammoCAT DM will be upgradeability to MammoCAT DBT, our second product, which will allow image capture over multiple angles to give it digital breast tomosynthesis capability.