NeuroLogica Corp, a subsidiary of Samsung Electronics, has announced that its latest configuration of the OmniTom® Elite mobile computed tomography (CT) scanner, equipped with Photon Counting Detector (PCD) technology, has received 510(k) clearance from the United States Food and Drug Administration (FDA). This advancement builds upon the existing capabilities of PCD with innovative enhancements, further solidifying the OmniTom® Elite’s position at the forefront of mobile CT imaging technology.
The new 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-processing features such as Virtual Non-Contrast (VNC) and bone removal, enhancing diagnostic capabilities and image quality.
Expanded Scanning Field: PCD scanning capabilities now cover a full 30 cm 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 ambient operating temperature has been increased, expanding the range of conditions in which the device can be used.
These improvements mark a significant advancement over the initial PCD configuration, which was already a pioneering achievement in mobile CT technology. The original OmniTom® Elite with PCD was the first single-source photon counting CT scanner, FDA approved with a single detector, capable of generating spectral CT images at multiple energy levels. This enhancement represents the third 510(k) clearance for the OmniTom® Elite PCD, demonstrating NeuroLogica’s continued commitment to innovation.
“Samsung and NeuroLogica’s technological innovation have resulted in FDA clearance for the OmniTom® Elite PCD,” said Kyu Tae Yoo, Head of Medical Equipment and Health Business at Samsung Electronics and CEO of Samsung Medison. “We will continue to develop leading technologies to enhance the convenience of medical personnel and diagnostic accuracy.”
Renaud Maloberti, Vice President and head of mCT Business at 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 more accurate diagnoses through enhanced 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 the OmniTom® Elite PCD.
Existing OmniTom® Elite customers can ‘UpTrade’ their scanners to the OmniTom® Elite PCD, giving them access to the latest advancements in photon counting technology.
*The OmniTom® Elite PCD is not currently FDA approved for neonatal or pediatric scanning and may not be commercially available in some countries. Sales and shipments are effective only after regulatory equipment approval. Please contact your local sales representative for more 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 providing fast, easy, and accurate diagnostic solutions to healthcare providers. NeuroLogica is the global corporate headquarters and manufacturer of mobile CT devices. NeuroLogica’s growing portfolio of advanced medical technologies is utilized worldwide in major healthcare institutions, helping providers improve patient care, increase patient satisfaction, and enhance workflow efficiency. For more information, visit: www.NeuroLogica.com.
Referrer: MiMub in Spanish
