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：
10580860
负责人：
Shabbir Bakir Bambot
金额：
$ 97.93万
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 2025-02-28
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10580860
关键词：
3D Print Address Appearance Architecture Attention Biopsy Bone Tissue Breast Breast Cancer Detection Breast Microcalcification Callback 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 Specific qualifier value System Technology Testing Thinness Time Tube United States Validation Woman Work attenuation commercialization compliance behavior contrast imaging cost cost effective design improved lifetime risk malignant breast neoplasm manufacturing cost 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.

项目摘要乳腺癌仍然是美国女性癌症与癌症有关的主要原因。乳房X线摄影是唯一批准用于乳腺癌种群筛查的成本效益方法，失败了在许多女性中找到癌症，并导致其余的不必要的回电话。 Fischer成像已经开发了专有的“老虎机扫描”技术，可显着改善对比度和形象分辨今天的乳房X线摄影并降低辐射剂量。我们的技术也删除了需要疼痛的乳房压缩。这些基本增强将提高临床性能通过发现错过的癌症并减少不必要的治疗，同时增加患者遵守乳房X线摄影建议。该提案描述了发展和可行性台 Mammocat™DM的测试，这是我们的第一个产品，它将提供两种视图X线摄影。该产品被视为II类，510K设备以及CMS和私人付款人允许具有平均患者量的设施在大约一年内还清设备。一个 Mammocat DM的主要功能将升级到我们的第二个产品Mammocat DBT，该产品将允许在多个角度捕获图像以赋予其数字乳房断层合成能力。