NeuroLogica Announces FDA 510(k) Clearance for Photon Counting Computed Tomography Using OmniTom Elite – Samsung Global Newsroom

The world of medical imaging is no longer just black & white. NeuroLogica Corp, a subsidiary of Samsung Electronics, announced today its state-of-the-art OmniTom Elite has received 510(k) clearance for the addition of Photon Counting Detector (PCD) technology. NeuroLogica delivers the first FDA 510(k) cleared, single-source photon counting computed tomography (CT) scanner with single detector. OmniTom Elite can produce spectral CT images with multiple energy levels using PCD.

Photon counting is a next-generation CT technology that sorts the different energies of X-rays after they have passed through the scan field. A PCD and X-ray sources can be used to generate multiple sets of CT data at once. Each set has a configurable threshold energy, so there is no crosstalk between the images. PCD 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. There is also potential with PCD to lower the dose requirements, and fundamentally change the use of injected contrast.

“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,” said David Webster, Chief Operating Officer of NeuroLogica. We are excited to offer PCD technology on the OmniTom Elite platform. This will allow us to improve the diagnosis of CT at the bedside .”

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The OmniTom Elite has the ability to provide versatile, real-time mobile imaging to administer point-of-care CT to critical patients without the need to transport them to a separate imaging department. This mobile unit can reduce the time required to diagnose these patients and start treatment.

“Availability of photon-counting detector technology on a mobile head CT platform is a significant advance in the development of CT,” said Rajiv Gupta, PhD, MD, Neuroradiology Division Chief of Massachusetts General Hospital and Associate Professor at Harvard Medical School. “This advance heralds a new era of CT applications in stroke, trauma, ICU and intra-op settings.” MGH is collaborating with NeuroLogica and will pilot test the OmniTom Elite with PCD to monitor post-trauma and post-surgical patients.

Upgrading capabilities were top of mind when designing OmniTom Elite mobile CT scanners. In the near term, all current OmniTom users will have the opportunity to upgrade their scanners with this technology. Meanwhile, a limited number of premier research partners will aid in developing the full potential of OmniTom Elite with PCD.

Neurologica’s OmniTom Elite, and the entire mobile CT product line are manufactured in Danvers, MA, USA.

To stay informed about our PCD products, events and future developments please sign up on our website: https://www.neurologica.com/mobile-ct/PCD

About NeuroLogica

NeuroLogica Corp., the healthcare subsidiary of Samsung Electronics Co., Ltd., develops, manufactures and markets innovative imaging technologies and is committed to delivering fast, easy and accurate diagnostic solutions to healthcare providers. NeuroLogica, the worldwide corporate headquarters and global manufacturer of mobile computed-tomography devices, is also known as NeuroLogica. NeuroLogica’s growing portfolio of advanced medical technologies is used worldwide in leading healthcare institutions helping providers enhance patient care, improve patient satisfaction and increase workflow efficiency. For more information, please visit: http://www.NeuroLogica.com.