PLYMOUTH, Mich., Dec. 14, 2018 /PRNewswire/ -- EhmetDx announced today that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its innovative 3D CBCT positioning software to be used in patient treatment at the McLaren Proton Therapy Center. The system is used to precisely guide the position of the proton beam in patient treatments, which will begin in December 2018.
Michael Teicher, Founder and CEO states, "We look forward toward patient treatment using our software for positioning now that the FDA concluded that our X-ray positioning system has met the requirements needed for 510(k). With patient treatment imminent, our team will turn its efforts to focus on commercialization of the Mammoknife: the world's first self-shielded, linac-based breast cancer radiotherapy device that will raise the standard of treatment for women globally."
EhmetDx is a Delaware entity headquartered in Plymouth, Michigan, and was founded with the goal of commercializing the latest identifiable needs of the medical market. We are a consortium of health care focused engineers, scientists and executives from diverse backgrounds that have collaborated to bring a sense of integrity and execution to the device industry.
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