The US Food and Drug Administration (FDA) has given medical device company EhmetDx 510(k) clearance for its positioning software X-Ray 3D CBCT. The firm will use the positioning software to treat patients at the McLaren proton therapy center.
Using the CBCT system, the professionals can precisely know the position of the proton beam during the treatment of patients, which will most probably start by the end of December.
Michael Teicher, founder and CEO of EhmetDx, said that they are very excited to see how their software for positioning works in patient treatment now, when the FDA has approved the X-ray positioning system for 510(k).
Teicher added that the patient treatment is impending as of now, and thus, they are currently focusing on commercialization of the Mammoknife, which is the first self-shielded, linac-based breast cancer radiotherapy device in the world. He mentioned that the device is likely to raise the standard of treatment for women across the world.
EhmetDx had joined hands with Orbital Therapy of Waltham, last year, to obtain the exclusive rights for its MammoKnife radiotherapy device. This device is claimed to be the first self-shielded radiotherapy treatment for breast cancer in the world. The patented device was created by Alan Sliski, one of the co-founders of both PhotoElectron Still River Systems. Medical professionals can use MammoKnife in any treatment center or medical office without any need of extra expensive bunkers or shielding.
EhmetDx is formed by a group of healthcare-focused engineers, executives and scientists, belonging to diverse backgrounds. The team at the company is specialized in commercializing medical devices, particularly the ones meant for medical imaging and particle beam therapy.
In Plymouth, EhmetDx runs FDA-registered facility, which has been involved in producing and offering devices to the Fortune 500 community for more than 14 years now. The facility is located adjacent to 50,000ft² advanced design and assembly space of EhmetDx manufacturing partners.
EhmetDx has been commercializing the latest advancements in medical device technology to meet the identifiable needs of the medical market. The firm mainly focuses on particle beam therapy and cone beam computed tomography. It aims to provide highly beneficial experiences in radiotherapy.