NeuroLogica Gets FDA’s 510(k) Clearance for Its OmniTom Elite Medical Imaging

March 16, 2022

NeuroLogica’s medical imaging system OmniTom Elite has received the FDA’s 510(k) clearance with added technology that offers better visualization of X-rays.

The photon-counting technology sorts the different energies of X-rays after they have passed through the scan field, so a single X-ray source can generate multiple sets of computed tomography (CT) data.

The imaging system offers more accurate visualization and segmentation of bone, blood clots, plaque, hemorrhage and intracranial tumors, as well as lower radiation dose requirements, the company said.

Danvers, Mass.-based NeuroLogica is a subsidiary of Korean tech giant Samsung Electronics.

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