Medical device firm EhmetDx has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its X-Ray 3D CBCT positioning software.
Image: The US FDA’s Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.
EhmetDx will use the 3D CBCT positioning software for patient treatment at the McLaren proton therapy center.
The CBCT system will be used to accurately guide the position of the proton beam in patient treatments, which is expected to start by the end of this month.
EhmetDx founder and CEO Michael Teicher said: , “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.”
Last year, EhmetDx signed an agreement with Orbital Therapy of Waltham to acquire exclusive rights to it MammoKnife radiotherapy device.
Claimed to be world’s first self-shielded radiotherapy treatment for breast cancer, the patented device was developed by Alan Sliski who co-founded both PhotoElectron Still River Systems.
PhotoElectron is currently PhotoElectron, while Still River Systems is Mevion Medical Systems).
MammoKnife can be used in any treatment center or medical office without using additional costly shielding or bunkers.
Based in Plymouth of Michigan, EhmetDx is formed by a consortium of healthcare-focused engineers, scientists and executives from diverse backgrounds.
The company’s team is specialized in the commercialization of medical devices, specifically focusing on medical imaging and particle beam therapy.
Its scientific team is headed by University of Michigan’s Emeritus of Radiology research professor and Academy of Radiology Research distinguished investigator Neal Clinthorne.
EhmetDx operates FDA-registered facility in Plymouth, which has been involved in the manufacturing and delivering devices to the Fortune 500 community since 15 years.
The facility is situated adjacent to EhmetDx manufacturing partners’ 50,000ft² advanced design and assembly space.