Description
In March 2026, GE HealthCare has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Photonova™ Spectra, an innovative photon‑counting computed tomography (PCCT) solution powered by the company’s 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.
Photonova Spectra is designed for the realization of the full potential of photon-counting CT in oncology, cardiology, neurology and more.
For nearly 50 years, CT has been a vital imaging tool used by clinicians for the diagnosis of disease, trauma, and abnormalities, as well as for planning, guiding, and monitoring therapy. Designed to build on this legacy, Photonova™ Spectra is the first in a next generation of full spectral photon-counting CT systems powered by Deep Silicon, 8-bin resolution to help expand what CT can deliver tomorrow.
G-MedTech –
“Photonova Spectra reflects years of intentional design and close collaboration with clinicians, researchers and collaborators across the globe. From 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’s care teams, as well as the imaging challenges and research opportunities that will shape the future of CT.”
— Jean-Luc Procaccini, President & CEO, Molecular Imaging and Computed Tomography, GE HealthCare.
G-MedTech –
“Elevating diagnostic confidence, particularly with subtle low-contrast structures, requires increasing clarity significantly to facilitate enhanced material differentiation. Being 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.”
— 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
G-MedTech –
“As clinicians across the United States face rising volumes and increasing diagnostic complexity, technology must do more than capture images; it must simplify decision-making and strengthen performance across the enterprise. Photonova Spectra is designed to deliver rich clinical insights in every scan and help alleviate cognitive 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.”
— Catherine Estrampes, President & CEO, U.S. and Canada, GE HealthCare