FDA clears mobile CT scanner from Samsung’s NeuroLogica

The BodyTom 64. [Image from NeuroLogica]NeuroLogica — a Samsung Electronics subsidiary — announced today that it received FDA 510(k) clearance for its BodyTom 64 scanner.

Danvers, Massachusetts-based NeuroLogica designed its BodyTom 64 for point-of-care mobile computed tomography (CT).

BodyTom 64 offers revisions to the company’s software and data acquisition system (DAS) based on customer feedback. NeuroLogica incorporated Linux as the operating system and provided the ability to generate up to 64 cross-sectional CT images. This compares to 32 images produced by the previous version, the BodyTom Elite.

The scanner offers multi-departmental imaging that stretches across various needs. It can turn an operating room into an intraoperative neuro-imaging suite when combined with a radiolucent skull fixation device. This enhances neuro-navigation and surgical outcomes, according to a news release.

Additionally, BodyTom 64 combines internal lead shie…

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FDA clears NeuroLogica’s OmniTom Elite with photon-counting detector technology

[Image from NeuroLogica]Samsung Electronics subsidiary NeuroLogica announced today that it received FDA 510(k) clearance for new technology on its OmniTom Elite.

Danvers, Massachusetts-based NeuroLogica’s OmniTom Elite computed tomography (CT) scanner now has single-source photon-counting detector (PCD) technology, allowing it to generate spectral CT images at multiple energy levels.

NeuroLogica said in a news release that its platform represents the first FDA 510(k)-cleared, single-source photon-counting CT scanner with a single detector on a mobile system. Next-generation photon counting allows for the sorting of different energies of X-rays after they have passed through the scan field.

The company said its PCD technology provides the ability to capture CT data in multiple energy bands, leading to potentially more accurate visualization and segmentation of bone, blood clots, plaque, hemorrhage and intracranial tumors. Additionally, PCD could help t…

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