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 Electronics will showcase its premium diagnostic imaging solutions in ultrasound, digital radiography and mobile computed tomography at the Radiological Society of North America (RSNA) 2020 Annual Meeting from November 29 to December 5.

“This year has been a pivotal year for Samsung in moving forwards new solutions across a variety of areas. We are looking forward to putting on display our advancements within ultrasound, digital radiography and mobile CT modalities,” stated Yongkwan Kim, Head of Health & Medical Equipment Business at Samsung Electronics and CEO of Samsung Medison. “Our innovative solutions demonstrate Samsung’s commitment to leveraging our innovation engine to better address the needs of healthcare providers and their patients.”

Ultrasound

Samsung will showcase the RS85 Prestige, which is designed to deliver outstanding scanning performance with consistent image clarity, depth of penetration and sensitivity to perfusion of blood flow to enhance abdominal and breast examination functionality. Above all, the RS85 Prestige delivers real-time images to clinicians, which is essential in ultrasound imaging.

New features:

• EzHRI assists in diagnosing fatty livers by showing the degree of the fatty liver after analyzing the ultrasound images and comparing the brightness level of the automatically selected location of hepatic parenchyma and renal cortex.
• TAI (Tissue Attenuation Imaging), TSI (Tissue Scatter distribution Imaging) provide quantitative tissue attenuation measurement and tissue scatter distribution measurement to assess steatotic liver changes.
• LA2-14A is an S-Vue Transducerwith single crystal technology, providing clear distinction in images of anatomical structures based on high SNR and deep penetration. As a single crystal transducer added to the high-resolution imaging technology, Crystal Architecture, useful images are provided for diagnosing thyroid and breast tumors as well as MSK tendon-related disorders.

Additional features deliver simplified workflow and accurate diagnoses:

• S-Detect simplifies breast examination processes by providing analysis of the selected lesion and standard reporting based on BI-RADS ATLAS*(Breast Imaging-Reporting and Data System, Atlas).
• S-Shearwave Imaging allows for non-invasive assessment of the stiffness of tissue/lesions in applications such as breast, liver, MSK and prostate, aided by color-coded elastogram, quantitative measurements, dual or single display options, and user-selectable ROI functions. It aids in the diagnosis of hepatocirrhosis and tumors.

Digital Radiography

Samsung is showcasing its premium digital mobile x-ray, the AccE GM85, which delivers unparalleled performance by improving diagnostic confidence and workflow. The AccE GM85, powered by a lithium-ion battery, in particular has demonstrated unprecedented performance during the recent pandemic. The AccE GM85 is suited to general imaging needs, and its practicality during the COVID-19 pandemic is highlighted through its unique feature set.

• Fast charging and long-lasting battery allows full charge within four hours, and the power to keep going all day without need for additional charging. With Li-ion battery technology, it offers enhanced stability in wider temperature ranges and its lead-free composition is more friendly for the environment.
• SimGrid streamlines workflow and reduces the total exam time by 28% by omitting grid installation and removal from the conventional workflow.
• S-Vue provides better image quality and significantly reduces radiation dosage during exams. The dosage can be reduced by up to 45% for pediatric abdomen, 15.5% for pediatric chest, and 27% for pediatric skull exams with the new S-Vue engine.¹

Samsung will be introducing two new enhanced software options for its line of DR equipment, including:

• Value Up Package 2021, a suite of workflow enhancement and diagnostic tools for Samsung DR systems including an AI algorithm that automatically provides a heads-up view of chest AP/PA; enhanced S-Align function with information of tube and detector angle to DICOM; and many other tools to deliver improved clinical care.
• Mirror View, real-time wireless screen mirroring to a Smart TV or Miracast-enabled display for use within an ER/Trauma or operating room environment.

Computed Tomography

Featured at RSNA are BodyTom^® Elite and OmniTom^® – mobile whole-body and head CTs. These mobile CTs can be used at the point of care, whenever imaging is needed to determine the ideal treatment strategy for a patient – without restrictions of physical space and power. Samsung’s NeuroLogica mobile CT devices are used by numerous leading institutions in intensive care units, emergency rooms, orthopedic and neurosurgery rooms, brachytherapy suites and ambulances.

In addition, Samsung will be presenting a Photon Counting Detector (PCD)² – cutting-edge technology that measures photons emitted by X-rays. The PCD, currently under development, has the potential to allow for dose optimization, allowing the user to reduce exposure while maintaining image quality, or increase the image quality by keeping dose equivalence compared to currently used CT detectors. The PCD is expected to deliver increased data mining capabilities from multiple-energy detection and contribute to the improved utility and efficacy of AI applications. Expanding from this, Samsung is closely collaborating with a major university hospital in the United States.

Samsung will host three Industry Sessions during RSNA:

• Featured Demonstration about advanced imaging technologies with RS85 Prestige will be held on December 3, from 5:00 p.m. CT – 5:30 p.m. CT.
• AI Theater Presentation: Application of On-Device AI in Healthcare, in collaboration with Intel,³ will discuss On-Device AI solutions that provide real-time feedback on ultrasound images and protect patients’ personal information. As a part of this collaboration, Samsung will host an Industry Session to address the differences between Cloud AI and On-Device AI, and the significance in ultrasound, available on demand throughout the duration of RSNA.
• Innovation Theater will highlight the performance of Auto Lung Nodule Detection (ALND)⁴ imaging application on chest radiographs of COVID-19 patients, available on demand throughout the duration of RSNA.

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 The S-Vue outcome is based on limited phantom and clinical study results. Only routine PA chest radiography and abdominal radiography for average adults and pediatric abdominal, chest, skull radiography were studied, excluding pediatric patients under 1 month old. (FDA cleared – K172229, K182183) In practice, the values of dose reduction may vary accordingly.

² Product is under development and not available for sale in USA or any region of the world.

³ Intel, the Intel logo, and other Intel marks are trademarks of Intel Corporation or its subsidiaries.

⁴ ALND is not available for commercial sale in the USA.