Xoran Announces FDA 510(k) Clearance for Truly Mobile Fluoroscopy-CT TRON™

Friday, August 05, 2022

Xoran Technologies® announces that last month it received FDA 510(k) clearance for TRON® — a truly mobile, full-body fluoroscopy, computed tomography (CT) X-ray system.

    “When Xoran states that TRON is the ‘One RING to rule them all,’ we truly mean that this compact, mobile, open-bore device is poised to revolutionize global initiatives to democratize access to diagnostic imaging,” says Xoran CEO Misha Rakic. “TRON is uniquely suited to provide safe, ultra-high-resolution, low dose imaging in traditional settings such as the operating room, surgery center, and critical care unit where space is limited, and hospital budgets are stretched thin.”

    “Its compact size and weight make it truly nimble without any need for bulky motors and batteries,” continues Rakic. “What’s more, because TRON scans take less than a minute, and the system is easy-to-use, it can be further mobilized by placing it in small vans, lending TRON to low-dose screening brought to patients and not the other way around. This means that Xoran’s Vehicle-Based Solutions™ can be used for community health initiatives and in ambulance and military front-line scenarios.”

Additionally, in July, Xoran announced it had begun work on Phase 2 of its mobile lung grant—the goal of which is to confirm the safety and utility of a future thoracic point-of-care CT system in support of an FDA submission. These research and development efforts for lung CT are supported by a recent grant award from the National Heart, Lung, and Blood Institute (NHLBI) through the National Institutes of Health (NIH).

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