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Medical Devices / Submissions and Approvals

EhmetDx Gets FDA Clearance for X-Ray Positioning Software

Dec. 18, 2018

The FDA granted 510(k) clearance for EhmetDx’s X-Ray 3D cone beam computed tomography positioning software.

The Plymouth, Michigan-based device manufacturer will market the positioning software for treatments using proton therapy.

The software is able to accurately guide the position of a proton beam during treatment. The first treatments will begin this month at the McLaren Proton Therapy Center in Flint, Michigan.

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