Samsung Electronics subsidiary NeuroLogica has secured 510(k) clearance for its BodyTom 64 Point-of-Care Mobile Computed Tomography (CT) Scanner from the US Food and Drug Administration (FDA).
The new head-to-toe trauma imaging solution has been designed to help healthcare specialists bring advanced imaging directly to their patients.
Through modifications to the software as well as the data acquisition system (DAS), NeuroLogica designed the new BodyTom 64 to improve clinical workflows and boost user experience based on customer feedback.
The company has also doubled the capacity of the new system, allowing it to generate up to 64 cross-sectional CT images of a patient’s body, and added Linux as the operating system.
The device can be used in a variety of settings, with indications for both paediatric and adult imaging.
It can turn an operating room into an intraoperative neuro-imaging suite when combined with any radiolucent skull fixation device.
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This enhances the neuro-navigation and surgical outcomes, as well as the clinical utility for extracranial procedures.
BodyTom 64 combines internal lead shielding and battery operation. This enables any standard trauma bay to be transformed into an advanced CT imaging suite.
Additionally, the device provides the ability to rescan each stage of needle guidance, bringing the multi-slice CT to the interventional suite.
NeuroLogica global sales and marketing senior director Jason Koshnitsky said: “We’re 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.
“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.”