Neurologica announces US FDA 510(k) clearance of BodyTom 64

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BodyTom 64
BodyTom 64

Neurologica, a subsidiary of Samsung Electronics, has announced that its head-to-toe trauma imaging solution—the BodyTom 64 point-of-care mobile computed tomography (CT) scanner—has received 510(k) clearance from the US Food and Drug Administration (FDA) for commercial use in the USA.

Based on customer feedback, the company designed the BodyTom 64 to enhance the user experience and improve clinical workflows through revisions to both the software and the data acquisition system (DAS), a press release states. Such revisions include incorporating Linux as the operating system and having the ability to generate up to 64 cross-sectional CT images of a patient’s body, versus the 32 images produced by the predicate BodyTom Elite system.

A Neurologica press release also details that, with indications for both paediatric and adult imaging, the BodyTom 64 is a multi-departmental imaging solution that can be utilised for various needs, including:

  • Neurosurgery/surgery—when combined with any radiolucent skull fixation device, it can transform an operating room into an intraoperative neuroimaging suite to enhance neuro-navigation and surgical outcomes, including clinical utility for extracranial procedures
  • Trauma/emergency room (ER)—its unique combination of internal lead shielding and battery operation allows any standard trauma bay to be transformed into an advanced CT imaging suite
  • Interventional radiology (IR)—it can also help optimise workflows by remaining ready to rescan for each stage of needle guidance, and bring the power of multi-slice CT to the interventional suite

“We are thrilled to build off our expertise and elevate point-of-care imaging with our BodyTom 64, which can transform any room in a hospital into an advanced imaging suite,” said Jason Koshnitsky, senior director of Global Sales and Marketing at Neurologica. “This full-body 64-slice CT scanner is an upgraded version of the BodyTom Elite CT scanner, providing enhanced functionality with the same high-resolution imaging capabilities.”


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