MammoCAT Advanced Full Field Digital Mammography System

Project Summary Breast cancer remains a leading cause of cancer related death among women in the United StatesMammographythe only cost effective method approved for population screening of breast cancerfails to find cancer in many women and causes too many unnecessary call backs on the restFischer Imaging has developed proprietaryslot scanningtechnology that significantly improves contrast and doubles the image resolution of today s mammography with less than half the radiation doseuptolowerOur technology also removes the need for painful breast compression which is the reason why many women avoid mammogramsThese essential enhancements will lead to improved clinical performance in breast cancer screening and diagnosis by finding missed cancersreducing unnecessary treatment and increase screening complianceThis proposal describes the development and feasibility bench testing of MammoCATDMour first productwhich will provide superior two view mammographyThis product is regulated as a Class IIk device and reimbursement is available from CMS and private payors allowing a facility with an average patient volume to pay off the device in about a yearA key feature of MammoCAT DM will be upgradeability to MammoCAT DBTour second productwhich will allow image capture over multiple angles to give it digital breast tomosynthesis capabilityFinallyMammoCAT CTor third productwill use the same gantry as our DBT device in a comfortableprone configuration where the breast is held pendant without compression and will perform full fielddegreeimaging at the same dose as standard digital mammographyMammoCAT CT will usher in a new era where tumors can be stagedlocalized and biopsied in the same device thus improving equipment and space utilization and improving hospital workflow Project Narrative Fischer Imaging s proposed products will improve breast cancer screening and diagnosis by finding missed cancersreducing unnecessary treatment and improving screening complianceAlthough X ray mammography continues to be the best and only option for breast cancer screening there is an urgent need to improve itparticularly for women with dense breastsOur proprietary technology enhances the image contrast and doubles the image resolution of today s mammography using only half the radiation doseThis 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 imagesOur technology also removes the need for painful breast compression because of which many women avoid mammograms thereby improving compliance with mammography recommendations