▲ 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.

▲ The high-tech, yet highly mobile OmniTom Elite with Photon Counting Detector (PCD) CT scanner is designed to offer advanced imaging at the point-of-care.

NeuroLogica Corp., a subsidiary of Samsung Electronics and a pioneer in premium diagnostic imaging solutions, will showcase its latest offerings in mobile computed tomography (CT) and feature the OmniTom^® Elite Photon Counting mobile CT scanner at the Radiological Society of North America (RSNA) Annual Meeting in Chicago from November 26 to November 30.

The clinical launch of the OmniTom Elite Photon Counting mobile CT scanner, a single-source photon counting computed tomography scanner utilizing NeuroLogica’s proprietary detector technology (PCD), will be featured at this year’s meeting. Photon counting is a next-generation CT technology that sorts the different energies of X-rays after they have passed through the scan field, capturing the X-ray photons directly at the detector and converting the energy to electrical signals.

The OmniTom Elite’s ability to provide versatile, real-time mobile imaging enables healthcare providers to administer point-of-care CT to critical patients without the need to transport them to a separate department, expanding the diagnostic possibilities of CT at the patient’s bedside.

“The OmniTom Elite is an advanced imaging solution that is extremely mobile, giving healthcare providers more flexibility in when and where they run diagnostic tests for their patients,” said Renaud Maloberti, Vice President, Head of Business, MCT. “We look forward to featuring this innovative technology at this year’s Radiological Society of North America Annual Meeting.”

NeuroLogica will showcase its innovation at Booth #6133, McCormick Place, and unveil the OmniTom Elite with PCD on Sunday, November 26 at 10:30 am CST, with a live demonstration of this state-of-the-art technology.

Also on Sunday, November 26 from 11:45 am to 12:45 pm CST in the South Building, Level 4, Room S403B, McCormick Place, Dr. Raj Gupta of Massachusetts General Hospital and Professor Iris Grunwald of the University of Dundee host the Samsung NeuroLogica Lunch & Learn Event “Photon Counting: The Next Generation of Neuro CT.” They will discuss how leveraging the latest innovation in CT applications may increase productivity and enhance the patient and physician experience.

For more information or to register, visit www.eventcreate.com/e/samsungrsna2023.

▲ Samsung will showcase its premium diagnostic imaging solutions in ultrasound, digital radiography and mobile computed tomography at the Radiological Society of North America (RSNA) 108th Scientific Assembly and Annual Meeting.

Samsung Electronics will be unveiling its latest artificial intelligence (AI) technologies and presenting its premium diagnostic solutions in ultrasound, digital radiography (DR) and mobile computed tomography (CT) at the Radiological Society of North America (RSNA) 108th Scientific Assembly and Annual Meeting from November 27 to December 1.

David Legg, Vice President, Head of Business, Boston Imaging, a subsidiary of Samsung, shares, “Samsung has a long-standing history of leading the charge in technology advancements – 2022 has been a testament to this as we have worked to redefine our cutting-edge solutions across modalities. We’re now deploying real-time on-device AI technology to help healthcare professionals examine and diagnose patients with ease and accuracy from the start.”

Samsung has remained focused on the critical clinical needs that elevate customer experience when developing new products. During the conference, the company will highlight 2022 achievements that worked to make the world a healthier place by empowering clinicians to diagnose their patients more confidently.

“Innovation is at the core of Samsung’s business. We take great pride in delivering our customers’ leading-edge technology on all Samsung devices,” said Kyu Tae Yoo, Senior Vice President, Global Head of Sales and Marketing, Samsung Medison. “As we look to expand diagnostic possibilities and improve the clinical experience that our customers need, we will keep healthcare professionals and the patients they treat top of mind.”

Additional details about the novel innovations Samsung will showcase during the conference can be found below.

Ultrasound

At the event, Samsung will showcase leading product updates, including the V7 ultrasound system, a new endocavity transducer and new real-time on-device AI solutions.

The new on-device AI solution for ultrasound, known as HeartAssist, which can enhance the diagnosis and examination process, will be on display. It’s a deep learning-based function that automatically finds the cross-section of the heart and measures different points needed for an accurate diagnosis. The automated nature allows for a streamlined workflow due to fewer keystrokes. The feature can be found on the V8 and V7 ultrasound systems.

Samsung also recently released the new V7 ultrasound system, which provides a wide array of clinical applications, including a range of on-device Intelligent Assist features such as BiometryAssist and UterineAssist, that enhance both the patient and user experience.

From general imaging to women’s health, it was designed to deliver a multi-faceted diagnostic experience. Crystal Architecture is the core of the V7’s enhanced image clarity and penetration and is built upon the combination of innovative beamforming (CrystalBeam), sophisticated image processing (CrystalLive) and advanced S-Vue Single Crystal Transducers to produce clear, uniform and high-resolution images.

The miniER7,¹ a new endocavity transducer, will be shown alongside the V7 ultrasound system. With a radius size of 7mm — 3mm smaller than the existing probe — the new probe was designed to ease the burden felt by healthcare professionals as well as the discomfort that patients often experience during prostate ultrasound scanning. The miniER7 was created with state-of-the-art micro-processing technology to capture clear images at a reduced file size.

Digital Radiography

Samsung is also showcasing its premium digital radiography solutions, including the new “Vision Assist” solution and AccE Glass Free Detector.

The AccE GC85A Vision² premium ceiling digital radiography system with “Vision Assist” provides more enhanced patient care and workflow efficiency maintaining an advanced low-dose imaging experience. Specifically, the AccE GC85A Vision focuses on new ways to increase efficiencies so healthcare professionals can streamline without compromising, including:

• Reduced Operation Time: The Intelligent Collimation and Stitching Auto Planning features provide the optimal collimated area automatically with just one click using deep learning technology. While the Patient Size Guide recommends patient size and optimal parameters based on the patient’s body thickness to save time.³
• Decreased Retake Error: The Virtual Overlay feature displays a virtual drawing of the receptor boundary and AEC chamber onto the patient to help the operator with patient positioning. The Motion Alarm based on machine learning technology can inform the operator of patient movements and falls. Virtual Collimation then allows the operator to make adjustments to the collimated area from the control room with ease.³
• Continuous Patient Care: The operator can continuously monitor the patient through Vision Live, which is a live camera in the tube head unit.

With a strategic focus on workflow optimization, Samsung also recently released a new flagship detector, the AccE Glass-Free Detector, which offers a more comfortable imaging experience without compromising image quality. Designed to deliver high-resolution images of a lightweight digital detector, it provides additional user and patient benefits, including:

• Functionality: It boasts a non-glass flexible panel with center-engraving to position a patient, a side chamfer to ease lifting and a rear grip to support transportation. It also weighs 27% lighter than the conventional model⁴ (approximately 4.5 pounds).⁵
• Reliability: Its high load allowance (up to 881 pounds of surface load and 441 pounds of patient load)⁶ and dust and water-resistant design allows for reduced user concern in complex environments like the ER and OR.
• Clear Visibility: It exhibits a 76% DQE, leading the market in glassless panel technology.

Computed Tomography

Also featured at RSNA is the OmniTom^® Elite with Photon Counting Detector (PCD) technology and BodyTom^® 64.

The state-of-the-art 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. With the addition of PCD technology, the system provides the ability to capture CT data in multiple energy bands. The multiple sets of CT data are acquired at the same time with configurable energy thresholds without any cross talk between images. The PCD system⁷ brings multi-energy CT functionality with spectral capability for material decomposition, virtual monoenergetic images (VMI) and soft tissue identification.

The BodyTom^® 64 is an upgraded version of the BodyTom^® Elite CT scanner, providing enhanced functionality with high-resolution imaging capabilities. The head-to-toe trauma imaging solution boasts revisions based on customer feedback, with indications for both pediatric and adult imaging and can be used for low dose lung cancer screening. The BodyTom^® 64 is a multi-departmental imaging solution that can be utilized in neurosurgery, interventional radiology, brachytherapy, trauma, medical examination and more.

Environmental, Social and Governance

Samsung not only focuses on advancing its diagnostic solutions and technologies, but also takes part in protecting the environment by developing eco-friendly packages as a part of its environmental, social and governance management.

Expanded Polyethylene foam (EPE) foams that were previously used in the ultrasound packages were replaced by recycled papers, resulting in the reduction of 15 tons of EPE foams in 2022. Samsung’s goal is “Zero” usage of EPE foams by 2023. In addition, polyurethane materials that were used for transducer packages are also being replaced by recycled papers, expecting to reduce the usage of polyurethane to 8 tons.

Visit Samsung at Booth # 2165. To learn more about the Samsung products on display and other events visit: https://samsunghealthcare.com/en/rsna2022.

About Boston Imaging

Boston Imaging markets innovative imaging technologies and is committed to delivering fast, easy and accurate diagnostic solutions to healthcare providers. Boston Imaging is the United States headquarters for sales, marketing and distribution of all Samsung digital radiography and ultrasound systems. Boston Imaging’s growing portfolio of advanced medical technologies is used in leading healthcare institutions helping providers enhance patient care, improve patient satisfaction and increase workflow efficiency. For more information, please visit https://www.bostonimaging.com/.

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 are 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 miniER7: Pending FDA 510(k) clearance, not available for sale within the United States

² The AccE GC85A Vision is a sub configuration of The AccE GC85A

³ Compared to the current AccE GC85A configuration, without a camera solution

⁴ Compared to S4335-AW

⁵ Measured without battery set

⁶ Based on 40 mm diameter disc at the center

⁷ OmniTom^® Elite with PCD: Pending FDA 510(k) clearance, not available for sale within the United States

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.

“This has been a momentous year for Samsung. We have worked to advance our solutions by leveraging high computing power and artificial intelligence (AI) technologies,” said David Legg, Vice President, Digital Radiography and Ultrasound, NeuroLogica. “We will be deploying AI features in each of our products to provide benefits to healthcare professionals and patients alike.”

Ultrasound

At the event, Samsung will showcase its new V8, which is a premium ultrasound system that provides enhanced image quality, usability and convenience for ultrasound professionals. Crystal Architecture is the core of the V8’s image clarity and penetration and is built upon the combination of innovative beamforming (CrystalBeam), sophisticated image processing (CrystalLive) and advanced S-Vue Single Crystal Transducers to produce clear, uniform and high-resolution images.

The feature-packed device includes two new AI functions, one being NerveTrack, which detects nerves and provides nerve location information in real-time to anesthesiologists and expert practitioners. The function is designed to provide users with accurate nerve detection, faster image processing and better workflow support. The second AI function is UterineAssist, which detects tissue changes and assists the user in taking measurements of the uterus. With these and other new tools, the V8 delivers a new level of versatility and value to a wide range of diagnostic medical ultrasound departments.

Samsung has also worked to advance its ultrasound solutions for women’s health. Recently, the Hera W9 and W10 received Food and Drug Administration (FDA) 510(K) clearance for its new AI functions, which gives the operator the ability to measure anatomical structures and analyze imaging, providing useful information to aid diagnosis.

New features include:

• HeartAssist: A deep learning-based function that provides classification of ultrasound images to display measurements. The feature recognizes various views and proposes caliper placements and corresponding measurements allowing users to save time with measurement proposals and increase examination efficiency by reducing keystrokes.
• ViewAssist: A deep learning-based function that classifies ultrasound images to deliver key scanning views and provides annotations. The feature recognizes a range of views, proposes corresponding anatomy annotations and initiates measurements.
• BiometryAssist: An automatic solution for biometric measurement that can be modified by the user. It enables users to measure fetal growth parameters with one click while maintaining exam consistency.

Digital Radiography

Samsung is also showcasing its premium digital mobile X-ray, the AccE GM85, which delivers unparalleled performance and gives users better diagnostic confidence while improving workflow. Recently, Samsung received FDA 510(k) clearance for its Auto Lung Nodule Detection (ALND) tool, which can be utilized in the AccE GC85A and in other systems. The ALND is provided as an on-device computer-assisted detection (CADe) software that uses an AI algorithm to detect pulmonary nodules between 10 and 30mm in size.¹

The benefits of ALND include:

• Aids the user in the diagnostic process by indicating the location of suspected lung nodules on chest X-ray images (posteroanterior chest radiographs).
• Offers the option (Autorun) to automatically perform nodule detection immediately after chest X-ray imaging in addition to PACS transmission options to suit the hospital environment, both of which simplify the user’s workflow.
• The ALND has been clinically verified by multiple university hospitals and has been approved with a sensitivity of 80% or more.² As part of Samsung’s commitment to advancing diagnostic radiology using AI, Samsung will expand the uses of the chest CADe solution and continue improving diagnostic accuracy and workflow.

Computed Tomography

Also featured at RSNA is the OmniTom^® Elite – a mobile computed tomography (CT) scanner that delivers high-quality non-contrast CT, CT angiography and CT perfusion scans at point-of-care. The OmniTom Elite CT boasts a small footprint and high-resolution image quality. The advancements of the scanner help to optimize diagnostic confidence, speed and workflow across departments, such as neurosurgery, pediatric imaging, critical care, diagnostic radiology and more.

Earlier this year, NeuroLogica announced that the OmniTom Elite with Photon Counting Detector (PCD) technology will be piloted by Massachusetts General Hospital, bringing CT imaging to the patient’s point-of-care. Pending FDA 510(k) clearance, the hospital is testing the OmniTom Elite with PCD to monitor post-trauma and post-surgical patients.

The OmniTom Elite’s ability to provide versatile, real-time mobile imaging enables healthcare providers to administer point-of-care CT to critical patients without the need to transport them to a separate department. The mobile unit will decrease the time it takes to diagnose and initiate treatment for patients in the ICU. During the pilot stage for the OmniTom Elite with PCD, Massachusetts General Hospital will guide best practices and evaluate use cases for the novel system.

Visit Samsung at Booth #6952.

Samsung will showcase its premium diagnostic imaging solutions in ultrasound, digital radiography and mobile computed tomography at the Radiological Society of North America (RSNA) 2021 Annual Meeting.

About Samsung Medison Co., Ltd.

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 Corp.

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.

* Content has been updated as of February 10, 2023 to more accurately reflect product information.

¹ ALND cannot be used on patients who have lung lesions other than abnormal nodules.

² Y. Sim et al, Deep Convolutional Neural Network-based Software Improves Radiologist Detection of Malignant Lung Nodules on Chest Radiographs. Radiology, 2020