MammoCAT Advanced Full Field Digital Mammography System

MammoCAT 先进的全视野数字乳腺 X 线摄影系统

基本信息

批准号：
10481694
负责人：
Shabbir Bakir Bambot
金额：
$ 102.34万
依托单位：
FISCHER IMAGING, INC.
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-03-01 至 2024-02-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10481694
关键词：
3D Print Address Appearance Architecture Attention Back Biopsy Bone Tissue Breast Breast Cancer Detection Cancer Etiology Cessation of life Chest wall structure Clinical Computer software Custom Development Devices Diagnosis Digital Breast Tomosynthesis Digital Mammography Disease Dose Enhancement Technology Evaluation Filtration Future Image Laboratories Low Dose Radiation Malignant Neoplasms Mammography Measurement Mechanics Methods Pain Patients Performance Phase Population Privatization Probability Procedures Production Quality Control Radiation Dose Unit Radiation Scattering Reading Recommendation Resolution Rest Roentgen Rays Safety Scanning Services Shapes System Technology Testing Time Tube United States Validation Woman Work attenuation base calcification commercialization compliance behavior contrast imaging cost cost effective design improved lifetime risk malignant breast neoplasm mortality novel prototype radiation risk radiological imaging radiologist research clinical testing screening soft tissue tomosynthesis tool tumor unnecessary treatment usability young woman

项目摘要

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.

项目概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光检查是唯一被批准用于乳腺癌人群筛查的具有成本效益的方法，但失败了在许多女性中发现癌症，并导致对其他人进行过多不必要的回电。开发了专有的“槽扫描”技术，可显着提高对比度和图像我们的技术还消除了当今乳房X光检查的分辨率并降低了辐射剂量。这些必要的增强将改善临床表现。通过发现遗漏的癌症并减少不必要的治疗，同时提高患者的依从性该提案描述了乳房X线摄影建议的开发和可行性。测试我们的首款产品 MammoCAT™ DM，它将提供卓越的双视图乳房 X 线摄影。该产品被监管为 II 类 510k 设备，并且由 CMS 和当前程序报销私人付款人允许具有平均患者量的机构在大约一年内还清该设备的费用。 MammoCAT DM 的主要特点是可升级到我们的第二个产品 MammoCAT DBT，将允许从多个角度捕获图像，从而赋予其数字乳腺断层合成能力。