NeuroLogica Corp Receives FDA 510(k) Clearance for Enhanced OmniTom® Elite with Ultra-High Resolution PCD Technology
DANVERS, Massachusetts – July 15, 2024 – NeuroLogica Corp, a subsidiary of Samsung Electronics Co. Ltd., 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' Medical Device 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.
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About Samsung Electronics Co., Ltd.
Samsung inspires the world and shapes the future with transformative ideas and technologies. The company is redefining the worlds of TVs, smartphones, wearable devices, tablets, home appliances, network systems, medical imaging, and memory, system LSI, foundry and LED solutions, and delivering a seamless connected experience through its SmartThings ecosystem and open collaboration with partners. For the latest news, please visit the Samsung Newsroom at news.samsung.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 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.
* 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.
Media Inquiries
Toni Rice Huston THuston@NeuroLogica.com