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 to lower dose requirements and fundamentally change the use of injected contrast, the company said.
NeuroLogica said OmniTom Elite can provide versatile, real-time mobile imaging to administer point-of-care CT to critical patients without having to transport them to a separate imaging department, decreasing the time needed to diagnose and initiate treatment.
In the near term, OmniTom users will be able to upgrade their scanners with the technology, while a limited number of research partners will aid in developing the full potential of OMniTom Elite with PCD, the company added.
“NeuroLogica is driven by innovation. Since the advent of the world’s first multi-slice mobile CT in 2004, we have always known that point-of-care imaging can improve patient outcomes and increase the likelihood of a better quality of life after a traumatic event,” NeuroLogica COO David Webster said in the release. “With the introduction of PCD technology to the OmniTom Elite platform, we look to expand the diagnostic possibilities of CT at the patient’s bedside.”