GE HealthCare Wins FDA Nod for Photon-Counting CT Technology

GE HealthCare wins FDA nod for photon-counting CT technology

The 510(k) decision clears the company to challenge Siemens Healthineers for an emerging part of the CT imaging sector.

GE HealthCare’s Photonova Spectra photon-counting CT receives FDA clearance

CHICAGO--(BUSINESS WIRE)--Mar 23, 2026-

GE HealthCare advances imaging lineup with photon-counting CT system clearance

Photonova’s PCCT technology’s ‘universal scan’ approach is designed to drive efficiencies and reduce complexity across multiple CT exam types.The post GE HealthCare advances imaging lineup with photon-counting CT system clearance appeared first on Medical Device Network.

Photon-Counting CT: GE HealthCare FDA Cleared Spectra™

Cleveland, OH – March 15, 2026 – GE HealthCare has secured FDA 510(k) clearance for its groundbreaking Photonova Spectra, a photon-counting computed

FDA Clears GE HealthCare’s Photonova Spectra Photon-counting CT

Photonova Spectra introduces the next generation of spectral photon-counting CT technology with 8‑bin energy resolution and a one‑scan universal workflow designed to boost efficiency and reduce complexity across a wide range of CT exams.

GE HealthCare Secures FDA 510(k) Clearance for Photonova Spectra Photon-Counting CT

What You Should Know The Milestone: GE HealthCare has officially received FDA 510(k) clearance for Photonova Spectra, its highly anticipated photon-counting computed tomography (PCCT) system.The Core Technology: Unlike traditional CT scanners that convert X-rays into visible light before measuring them, PCCT directly counts individual photons and measures their energy. GE is utilizing a proprietary Deep Silicon detector architecture that provide…