MammoCAT Advanced Full Field Digital Mammography System

MammoCAT 先进的全视野数字乳腺 X 线摄影系统

• 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
• 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

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相关死亡的主要原因。 乳房X光检查是唯一一种被批准用于乳腺癌人群筛查的成本效益高的方法， 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。Fischer成像 开发了专有的“狭缝扫描”技术，显著提高了对比度和图像质量。 提高了当今乳房X光摄影的分辨率，降低了辐射剂量。我们的技术还能去除 需要痛苦的乳房压迫。这些重要的增强功能将提高临床性能 通过发现遗漏的癌症，减少不必要的治疗，同时提高患者对 乳房X光检查建议。本提案描述了开发和可行性工作台 测试我们的第一款产品MammoCAT™ DM，该产品将提供出色的上级双视图乳腺X射线摄影。 本产品被CMS监管为II类510k器械和当前程序报销， 私人支付者允许具有平均患者量的设施在大约一年内付清该设备。一 MammoCAT DM主要特点是可与我们的第二款产品MammoCAT DBT兼容， 将允许在多个角度上捕获图像，以赋予其数字乳房断层合成能力。