▲ NeuroLogica’s OmniTom® Elite with PCD technology has received U.S. FDA 510(k) clearance.

NeuroLogica Corp, a subsidiary of Samsung Electronics, announced its latest configuration of the mobile computed tomography (CT) OmniTom^® Elite with Photon Counting Detector (PCD) technology has received U.S. Food and Drug Administration (FDA) 510(k) clearance. This advancement builds upon the existing PCD capabilities with groundbreaking enhancements, further solidifying OmniTom^® Elite’s position at the forefront of mobile CT imaging technology.

The newly cleared features optimized for PCD include several significant innovations:

• Ultra-High-Resolution Mode: This development promises unprecedented clarity and detail in CT imaging. The addition of an ultra-high-resolution mode now offers an impressive 0.141 mm resolution.
• Advanced Image Processing Algorithm: The OmniTom^® Elite now supports post-reconstruction features such as Virtual Non-Contrast (VNC) and bone removal, enhancing diagnostic capabilities and image quality.
• Expanded Scanning Scope: The PCD scanning capabilities now cover a full 30cm field of view, ensuring comprehensive imaging potential for a variety of clinical applications.
• Helical Scanning Capability: This new feature allows for continuous spiral scanning, providing a faster and more efficient imaging process.
• Enhanced Operating Environment: The operating environment ambient temperature has been increased, broadening the range of conditions in which the device can be used.

These enhancements mark a significant step forward from the initial PCD configuration, which was already a pioneering achievement in mobile CT technology. The original OmniTom^® Elite with PCD was the first FDA 510(k) cleared, single-source photon counting computed tomography scanner with a single detector, capable of generating spectral CT images at multiple energy levels. This enhancement marks the third 510(k) clearance for OmniTom^® Elite PCD, speaking to NeuroLogica’s commitment to continuous innovation.

“Samsung and NeuroLogica’s technological innovation has resulted in the FDA clearance of OmniTom^® Elite PCD,” said Kyu Tae Yoo, Head of Samsung Electronics’ Health & Medical Equipment Business and Samsung Medison CEO. “We will continue to develop leading technologies to improve medical staff’s convenience and diagnostic accuracy.”

Renaud Maloberti, Vice President & Head of mCT Business, NeuroLogica, commented, “Our commitment to innovation drives us to continually improve our products. With these new features, the OmniTom^® Elite PCD not only offers exquisite image quality and diagnostic capabilities but also ensures a more versatile and efficient imaging process. This is a significant advancement for point-of-care imaging, continuing our commitment to enable clinicians to make a more confident diagnosis due to the improved clinical information.”

The University of Dundee and Massachusetts General Hospital have partnered with NeuroLogica to collaborate on research aimed at pushing the boundaries of medical imaging in healthcare using OmniTom^® Elite PCD.

Existing OmniTom^® Elite customers can “UpTrade” their scanners to the OmniTom^® Elite PCD, granting them access to the latest advancements in photon counting technology.

* OmniTom^® Elite PCD is not currently US FDA 510(k) cleared for neonate or pediatric scanning and may not be commercially available in some countries. Sales and shipments are effective only after approval by the regulatory team. Please contact your local sales representative for further details. This product is a medical device; please read the user manual carefully before use.

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 is the global corporate headquarters and manufacturer of mobile computed tomography devices. 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: www.NeuroLogica.com.

NeuroLogica’s OmniTom Elite has received 510(k) clearance for the addition of Photon Counting Detector (PCD) technology.

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 with PCD can generate spectral CT images at multiple energy levels.

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 single X-ray source paired with PCD generates multiple sets of CT data acquired at the same time with configurable energy thresholds without any cross talk between 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. “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.”

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. The mobile unit will decrease the time it takes to diagnose and initiate treatment for these critical patients.

“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 is the global corporate headquarters and manufacturer of mobile computed tomography devices. 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.

“Samsung is continuing its commitment to deliver meaningful innovation in medical imaging, responding to customers’ ever complex healthcare needs,” said Dongsoo Jun, President of Health & Medical Equipment Business at Samsung Electronics and CEO of Samsung Medison. “We plan to continue our rapid pace of new innovation for the radiology market by leveraging our industry leading Image and Signal Processing and AI advances.”

On display at Samsung’s booth during the event are the following technologies:

Ultrasound System

RS85 Prestige¹, the evolution of the RS85, comes with new imaging Architecture and value added features.

RS85 Prestige

Imaging Architecture

• Crystal Architecture – an imaging architecture that combines CrystalBeam beamformer and CrystalPure imaging engine, combined with the S-Vue Transducer which provides crystal clear images.
• CrystalBeam – a new beamforming technology which delivers high-quality image resolution and increased uniformity of images.
• CrystalPure – Samsung’s latest ultrasound imaging engine with enhanced 2D image processing and color signal processing, offering outstanding image performance and efficient workflow in complex cases.

Value Added Features

• MV-Flow with LumiFlow – offers a detailed view of blood flow in relation to the surrounding tissues with enhanced spatial and temporal resolutions and provides three-dimensional visualization with continuous and 3D-like vascular images.
• ShadowHDR – provides a shadow suppressed image, which is especially useful in capturing highly attenuated regions behind bony structures.
• PureVision – an image processing function that produces clear images with uniformity by performing Speckle Noise Suppression and Edge Enhancement on B-mode.

Digital Radiography

Samsung is showcasing its premium ceiling X-ray GC85A and mobile X-ray GM85 which have been granted ATO (Authorization To Operate) for the Risk Management Framework (RMF) program set forth by the United States Department of Defense (DOD) for high level of cybersecurity regulations, while also exhibiting its new detector line-up with enhanced usability.

GM85

• S-Vue – provides high quality images for diagnostic accuracy and confidence. The S-Vue imaging engine’s adaptive filtering and processing technologies reduce X-ray radiation dose for pediatric patients without compromising the image quality. The dose level can be reduced up to 45% for pediatric abdomen, 15.5% for pediatric chest, and 27% for pediatric skull exams with the new S-Vue engine.
• Auto Lung Nodule Detection²– an AI-based CAD (computer-aided detection) software used to identify and detect lung nodules. It is designed to aid the physician in reviewing chest PA radiographs of adults. The new ALND feature is currently available for sale in Europe (CE marked) and Korea.
• SMART Center – an enterprise-level quality asset monitoring solution which aggregates data from multiple Samsung Digital Radiography devices into one easy-to-use platform. Users can reduce downtime and unnecessary tasks by having centralized control over the DR systems.

Computed Tomography

Samsung is highlighting additional mobile computed tomography (mCT) clinical cases demonstrating reduced response time by the medical team during emergencies, such as stroke, improving patient outcomes.

Featured at RSNA are BodyTom^® Elite and OmniTom^® – mobile whole-body and head CT. These mCTs can be used at the point of care, whenever imaging is needed to determine ideal treatment strategy for the patient – without restrictions of physical space and power. Samsung’s NeuroLogica mCT devices are routinely used by leading institutions in intensive care units, emergency rooms, orthopedic and neurosurgery rooms, brachytherapy suites and ambulances. In addition, Samsung Neurologica, in partnership with Winnebago, will be displaying a mobile lung screening vehicle, which will make this technology more accessible in remote areas.

OmniTom®

Lastly, Samsung will display a Photon Counting Detector (PCD)³ – cutting-edge technology that measures photons emitted by X-rays. PCD, currently under development, has the potential to allow for dose optimization allowing the user to reduce the exposure while maintaining image quality, or increase the image quality by keeping dose equivalence compared to currently used CT detectors. In addition, it should deliver increased data mining capabilities from multiple-energy binning and contribute to the improved utility and effectiveness of AI applications.

Visitors can experience Samsung’s differentiated diagnostic assistive functions and solutions directly at booth #4783 (South Building, Hall A).

Additionally, the attendees can also find a separate ‘AI zone’ that allows visitors to experience Samsung’s latest AI technology.

For more information on Samsung’s healthcare business, and products, please visit https://www.samsunghealthcare.com.

About Samsung Medison

Samsung Medison is a global leading medical device company, founded in 1985. With a mission to bring health and well-being of people’s lives, the company manufactures diagnostic ultrasound systems around the world across various medical fields. In 2011, Samsung Medison became an affiliate company of Samsung Electronics, integrating world’s best IT, image processing, semiconductor and communication technologies into medical devices.

About NeuroLogica

NeuroLogica, 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 global corporate headquarters and manufacturer of mobile computed tomography, is also the US headquarters for sales, marketing and distribution of all Samsung digital radiography and ultrasound systems. 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.

¹ RS85 Prestige is 510(k) pending and not available for sale in USA.

² ALND is not for sale in the United States.

³ Product is under development and not available for sale in USA or any region of the world.