EhmetDx Receives FDA Approval Letter for X-Ray CBCT 510(k) Submission
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.
Cautionary Statement on Forward-Looking Statements
Some of the statements in this press release are "forward-looking" and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements relating to, among other things, our planned commercialization efforts and regulatory approvals of our technologies as well as the success thereof and our research and development projects. These forward-looking statements are based upon the expectations of management under current assumptions at the time of this press release. We caution you that forward-looking statements are not guarantees of future performance and involve known and unknown risks, uncertainties and other factors that are in some cases beyond our control that may cause our actual results to differ materially from our expectations. We are providing this information as of the date of this press release and do not undertake any obligation to update any forward-looking statements contained in this presentation as a result of new information, future events or otherwise, unless we have obligations under the federal securities laws to update and disclose material developments related to previously disclosed information.