Molecular Breast Imaging

Project Goals

Gamma Medica needed a project management team to create a development plan for their software architecture and to implement a Quality Management System in line with US FDA, ISO-13485 and EU directives and to meet international, state and federal requirements.

Sunrise Solution

  • Created architecture and software lifecycle plans
  • Aligned software requirements with IEC 62304
  • Generated and implemented test plans, protocols, and reports
  • Coordinated, documented and implemented Quality and Regulatory initiatives with US FDA, ISO-13485 & EU Directives
  • Led IEC 60601-1 3rd Edition Testing, Documentation & Certification
  • Supported electronics design for compliance

Results

  • Featured on NBC Nightly News
  • American Journal of Roentgeneology (AJR) retrospective study confirmed Gamma Medica's Molecular Breast Imaging (MBI) technology had high incremental cancer detection rate of 7.7 cancers per thousand (7.7/1000) and overall clinical effectiveness as a secondary screening tool in finding 13 malignancies among 1,696 women with dense breast tissue following mammograms that read negative for cancer.
  • Mayo Clinic study determined that the addition of Molecular Breast Imaging (MBI) for women with dense breast tissue resulted in a lower cost per cancer detected than screening with mammography alone. The study found MBI technologies led to more accurate diagnosis rates, and in combination with mammography resulted in a cost savings of approximately 15 percent.
  • 2014 MEDICAL DESIGN EXCELLENCE AWARDS Bronze Winner
  • A simple, safe and accurate technology that will save lives