Photon-Counting CT System Gains CE Mark and Expands Access to Faster Diagnosis

The platform is engineered to deliver ultra-high-definition clarity, on-demand spectral and spatial imaging, and wide-coverage, fast acquisition to support confident detection, characterization, and monitoring. Announced on August 31, 2026, the CE Mark expands access to the system and enables clinical adoption across Europe and other CE-observing markets. Photonova Spectra previously received U.S. Food and Drug Administration 510(k) clearance and Japanese regulatory approval in March 2026.

Deep Silicon detectors are designed to measure photon energy precisely, enabling spectral imaging in every scan while maintaining high spatial resolution. The system’s ultra-high-definition imaging and wide coverage are intended to visualize subtle tissue variations, small lesions, and vascular structures at speed. To manage the substantial data volumes generated by photon-counting CT, Photonova Spectra uses NVIDIA’s accelerated computing platform and CUDA-optimized reconstruction. According to GE HealthCare, the system can harness up to 50 times more data than conventional CT while supporting timely, clinically actionable imaging.

Clinical applications described for Photonova Spectra span neurology, oncology, musculoskeletal imaging, thoracic imaging, and cardiology. Examples include visualization of inner ear microanatomy and grey-white matter differentiation; lesion characterization with iodine mapping for treatment monitoring; assessment of small fractures and bone marrow edema; ultra-high-definition chest imaging; and evaluation of in-stent lumen, plaque characteristics, and myocardium. A rotation speed of 0.23 seconds and 80 mm detector coverage are designed to support fast, motion-free acquisitions across care areas.

Workflow features include a one‑protocol setup for many exams, automated reconstruction of ultra‑high‑definition spectral images on demand, the CT ONE operator environment, and Auto Positioning to help improve consistency. GE HealthCare is collaborating with UZ Brussel – Vrije Universiteit Brussel and with Rigshospitalet to assess advanced capabilities, optimize imaging protocols, evaluate low‑dose and tissue characterization strategies, and generate clinical evidence. With CE Mark achieved, the company will begin commercial activities in CE‑observing countries.

“Deep Silicon brings a meaningful evolution to photon‑counting CT. Silicon's unique properties as a semiconductor enables precise photon energy measurement, helping power advanced spectral imaging capabilities,” said Johan de Mey, MD, PhD, Chair of Radiology, UZ Brussel - Vrije Universiteit Brussel.

"For us, that may offer new opportunities to differentiate materials like iodine, calcium and fat, as well as provide image quality that holds up even in challenging patient scenarios. Additionally, with Photonova Spectra’s rapid 0.23‑second rotation speed and 80 mm detector coverage, we can achieve fast, motion‑free acquisitions across care areas, helping ensure that detail and diagnostic confidence aren’t compromised. These advancements aim to provide a more reliable picture of how a condition is evolving or whether a treatment is truly working, supporting more timely and informed decisions for every patient," added Prof. de Mey.