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Monday, August 15, 2022

MEDICAL DEVICE NEWS MAGAZINE

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Xoran Technologies Submits FDA 510(k) Application for TRON

Xoran Technologies announced the company’s recent submission of an FDA 510(k) application for TRON™, an open-bore fluoroscopy computed tomography (CT) for full-body point-of-care imaging.

The potential new addition to Xoran’s suite of imaging systems offers potential benefits which include reduced transport risks to patients, improved accessibility to patient CT scans in limited spaces, and improved throughput for radiology departments.

With over 20 patents, this FDA 510(k) submission builds on the company’s continued research and development efforts for lung computed tomography (CT) imaging. Those research efforts have shown marked capability in point-of-care CT solutions for the neuro intensive care unit (NICU), the operating room, and satellite stations. The compact, mobile design and engineering of TRON for medical imaging marks a milestone towards optimizing a highly deployable CT scanner, and a point-of-care solution for patients beyond the designated confines of a limited space.

“This addition solidifies our commitment to improving patient accessibility to imaging at the point of care. The benefits of truly mobile compact devices cannot be underscored, and now by engineering the success of our head CT systems into an open-bore system, we are able to drive a new generation of Xoran’s point-of-care (POC) imaging devices,” said Misha Rakic, Xoran CEO.


Other FDA news items can be found here.

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