CHICAGO–(BUSINESS WIRE<\/a>)– This press release features multimedia. View the full release here: https:\/\/www.businesswire.com\/news\/home\/20260323095678\/en\/<\/a><\/p>\n GE HealthCare\u2019s Photonova Spectra photon-counting CT receives FDA clearance<\/p>\n<\/div>\n \nPhoton-counting CT represents a significant advancement in medical imaging. Unlike conventional CT systems \u2013 which first convert X-ray photons into visible light before measuring them \u2013 photon-counting CT directly counts individual photons and measures their energy. This approach enables higher spectral and spatial resolution as well as improved tissue characterization, helping provide clinicians with rich information to detect and diagnose disease with confidence.<\/p>\n \n\u201cAs clinicians across the United States face rising volumesii<\/sup> and increasing diagnostic complexity, iii<\/sup> technology must do more than capture images; it must simplify decision-making and strengthen performance across the enterprise,\u201d says Catherine Estrampes, President & CEO, U.S. and Canada, GE HealthCare. \u201cPhotonova Spectra is designed to deliver richclinical insights in every scan and help alleviatecognitive burden for care teams. With the U.S. 510(k) clearance, we are proud to now bring this innovation to U.S. healthcare systems and the patients they serve.\u201d<\/p>\n \nToday, Photonova Spectra stands out with the introduction of Deep Silicon, a novel detector material designed to enhance spectral imaging performance. Leveraging the purity and structural consistency of silicon \u2013 a high-performing semiconductor material \u2013 Deep Silicon enables the precise measurement of photon energy and delivers high levels of energy resolution, which are critical for advanced image reconstruction. This capability can allow clinicians to obtain spectral images with high levels of contrast, combined with detailed visualization across neurological, oncological, musculoskeletal, thoracic, and cardiac imaging.<\/p>\n \nFurthermore, Deep Silicon with 8-bin energy resolution supports advanced material separation and characterization capabilities. This enables Photonova Spectra to clearly distinguish between different materials such as iodine, calcium and fat with remarkable precision. Its wide detector coverage and rapid rotation speed (0.23 seconds) also support fast acquisition and motion-free imaging \u2013 even in challenging patient scenarios.<\/p>\n \nPhotonova Spectra automatically captures both 8-bin spectral and ultra-high definition spatial data simultaneously, without special setup or multiple protocols. This design gives clinicians access to spectral information in every exam, supporting confident decision-making and treatment monitoring in complex cases across specialties.<\/p>\n \n\u201cElevating diagnostic confidence, particularly with subtle low-contrast structures, requires increasing clarity significantly to facilitate enhanced material differentiation,\u201d shares Giuseppe Toia, MD, Assistant Professor of Radiology, Associate Section Chief of Abdominal Imaging and Intervention and CT Modality Chief with the Department of Radiology at the University of Wisconsin School of Medicine and Public Health. \u201cBeing involved in developing and testing the Deep Silicon detector has allowed us to see what this technology is capable of. During evaluative studies, this system allowed us to extract more clinically actionable information from a single scan to support informed decisions for research and clinical care. Because photon counting CT is a fundamentally different approach to imaging, we find it results in clean spectral signatures, high spatial resolution and accurate CT numbers.\u201d<\/p>\n \nTo process the increased data volumes produced by photon\u2011counting CT, Photonova Spectra incorporates NVIDIA accelerated computing technology. Designed to handle up to 50 times more data than conventional CT,iv<\/sup> the GPU\u2011powered architecture is intended to help maintain smooth, efficient workflows by leveraging NVIDIA\u2019s high-performance computing platform and CUDA-optimized reconstruction to turn massive spectral datasets into timely, clinically actionable images.<\/p>\n \nWorkflow efficiency is further supported by a one\u2011scan, universal full\u2011fidelity approach intended to reduce exam\u2011specific protocols and enable automated reconstruction of ultra\u2011high definition spectral images on demand. The CT ONE operator environment and automated features \u2014 including Auto Positioning \u2014 are designed to help improve consistency across GE HealthCare systems and simplify the overall CT process.<\/p>\n \nAltogether, Photonova Spectra\u2019s advanced architecture offers new opportunities for research in quantitative imaging, tissue characterization, and spectral biomarker discovery. To this end, GE HealthCare is collaborating with leading healthcare institutions across the United States to explore novel clinical applications and imaging protocols previously constrained by conventional CT technology:<\/p>\n \n\u201cPhotonova Spectra reflects years of intentional design and close collaboration with clinicians, researchers and collaborators across the globe,\u201d adds Jean-Luc Procaccini, President & CEO, Molecular Imaging and Computed Tomography, GE HealthCare. \u201cFrom the earliest stages to today, we remain focused on building a system that addresses the practical realities of clinical practice while opening pathways for scientific advancement. The result is a photon-counting platform engineered for the needs of today\u2019s care teams, as well as the imaging challenges and research opportunities that will shape the future of CT.\u201d<\/p>\n \nLeveraging GE HealthCare\u2019s platform architecture, Photonova Spectra also is purposefully designed for easy install and to fit into existing GE HealthCare CT ready rooms with minimal changes, preserving the foundational mechanical, electrical, and workflow design used across the Revolution family.<\/p>\n \nWith U.S. FDA 510(k) clearance now achieved, GE HealthCare will begin preparing for commercial availability in the United States.<\/p>\n \nNews of Photonova Spectra\u2019s 510(k) clearance quickly follows GE HealthCare\u2019s unveiling<\/a> of the technology at the Radiological Society of North America (RSNA) Annual Meeting in November 2025 \u2013 demonstrating the company\u2019s ability to move innovative technology from introduction to regulatory validation with speed and discipline.<\/p>\n \nFor more information on GE HealthCare\u2019s Photonova Spectra photon-counting CT system, visit gehealthcare.com<\/a>.<\/p>\n About GE HealthCare Technologies Inc.<\/b><\/p>\n \nGE HealthCare is a leading global healthcare solutions provider of advanced medical technology, pharmaceutical diagnostics, and AI, cloud and software solutions that help clinicians tackle the world\u2019s most complex diseases. Serving patients and providers for 130 years, GE HealthCare is delivering bold innovations designed for the next era of medicine across its Imaging, Advanced Visualization Solutions, Patient Care Solutions, and Pharmaceutical Diagnostics segments to help clinicians deliver more personalized, precise patient care. We are a $20.6 billion business with approximately 54,000 colleagues working to create a world where healthcare has no limits.<\/p>\n \nGE HealthCare is proud to be among 2026 Fortune<\/i> World\u2019s Most Admired Companies\u2122.<\/a><\/p>\n \nFollow us on LinkedIn<\/a>, Facebook<\/a>, Instagram<\/a>, or visit our website for our latest news<\/a> and perspectives<\/a>.<\/p>\n i<\/sup> Photonova Spectra is 510(k) cleared with the U.S. FDA. Not CE Marked. Not available for sale in Europe, Canada, or any other region. View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20260323095678\/en\/<\/a><\/span><\/p>\n GE HealthCare Media Contact KEYWORDS:<\/b> Illinois United States North America<\/p>\n INDUSTRY KEYWORDS:<\/b> Technology Medical Devices FDA Other Technology Health Technology Biotechnology Radiology General Health Health Oncology<\/p>\n
\nGE HealthCare (Nasdaq: GEHC) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Photonova\u2122 Spectra,i<\/sup> an innovative photon\u2011counting computed tomography (PCCT) solution powered by the company\u2019s novel Deep Silicon detector technology and offered as a flexible platform with multiple configurations to meet diverse clinical needs. With wide coverage and the combination of ultra-high definition (UHD) spatial and spectral imaging, Photonova Spectra helps enable fast acquisition speeds and the precise visualization of subtle tissue variations, small lesions and vascular structures.<\/p>\n![\"GE](\"https:\/\/mms.businesswire.com\/media\/20260323095678\/en\/2754594\/4\/Photonova_Spectra_-_GE_HealthCare.jpg\")
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ii<\/sup> Kaufman Hall. State of Hospital Volumes. Kaufman Hall, https:\/\/www.kaufmanhall.com\/insights\/infographic\/state-hospital-volumes<\/a>. Accessed October 6, 2025.
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iii<\/sup> Sittig, Dean F., and Hardeep Singh. A New Socio-technical Model for Studying Health Information Technology in Complex Adaptive Healthcare Systems. In: Henriksen K, Battles JB, Keyes MA, Grady ML, editors. Advances in Patient Safety: New Directions and Alternative Approaches (Vol. 1: Assessment). Rockville (MD): Agency for Healthcare Research and Quality (US); August 2008. https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK338593\/<\/a>. Accessed October 6, 2025.
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iv<\/sup> When compared to Revolution Apex Elite.<\/p>\n<\/p>\n
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Margaret Steinhafel
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M +1 608 381 8829
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margaret.steinhafel@gehealthcare.com<\/a><\/p>\n
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