Gamma Medica’s LumaGEM Molecular Breast Imaging (MBI) solution has been recognized as a finalist in the Radiological and Electromechanical Devices category of the 17th Annual Medical Design Excellence Awards (MDEA) competition. Finalists were first announced in the April issue of MD+DI (Medical Device and Diagnostic Industry) magazine. Winners will be announced at a June 11, 2014 ceremony held in New York City.
The LumaGEM technology was developed in partnership with Sunrise Labs to enable earlier breast cancer detection for women. Sunrise assisted in creating the development plan for the software architecture and acted in a project management capacity to coordinate, document, and implement the quality management system in accordance with FDA, ISO-13485, and EU directives. Sunrise also supported testing, documentation and the IEC 60601, 3rd Edition certification of the LumaGEM.
In a statement, Eric Soederberg, presient of Sunrise Labs, expressed gratitude for the opportunity to participate on Gamma Medica’s team. “Better detection of breast cancer and saving lives is what Sunrise’s medical device development engineers live to do,” he said.
For more information, visit Sunrise Labs.
