NeuroLogica Gets FDA Nod for New Mobile CT Scanner
Enhancements for the BodyTom 64 Point-of-Care Mobile Computed Tomography (CT) Scanner include upgraded cross-sectional imaging capabilities and a Linux operating system.
The Food and Drug Administration (FDA) has granted 510(k) clearance for the BodyTom® 64 Point-of-Care Mobile Computed Tomography Scanner, according to NeuroLogica, the manufacturer of the device and subsidiary of Samsung Electronics.
Incorporating clinician feedback in regard to the BodyTom Elite CT system, NeuroLogica doubled the capability of the BodyTom 64 system to generate upward of 64 cross-sectional images of a patient’s body and added a Linux operating system.
The device can reportedly be utilized in a variety of settings. For interventional radiologists, NeuroLogica said the BodyTom 64 provides multi-slice CT capabilities and facilitates easy rescans for stages of needle guidance. The BodyTom 64 device can provide neuroimaging guidance for extracranial procedures and is well-suited to trauma and emergency room settings with a unique combination of battery operation and internal lead shielding, added NeuroLogica.
“We’re thrilled to build off our expertise and elevate point-of-care imaging with our BodyTom64, which can transform any room in a hospital into an advanced imaging suite,” noted Jason Koshnitsky, senior director of Global Sales and Marketing at NeuroLogica.
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