Phase II year
2022
(last award dollars: 2023)
Phase II Amount
$2,002,658
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 todays 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. Public Health Relevance Statement Project Narrative Fischer Imagings proposed products will improve breast cancer screening and diagnosis by finding missed cancers, reducing unnecessary treatment and improving screening compliance. Although X-ray mammography continues to be the best and only option for breast cancer screening there is an urgent need to improve it, particularly for women with dense breasts. Our proprietary technology enhances the image contrast and image resolution of todays mammography with a lower radiation dose. This will make it easier for radiologists to identify features such as micro calcifications and fine tumor spicules indicative of cancer greatly improving their ability and confidence in reading mammography images. Our technology also removes the need for painful breast compression because of which many women avoid mammograms thereby improving compliance with mammography recommendations.
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