Molecular Breast Imaging
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.
- 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
- 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