GE HealthCare secured a CE mark for its photon‑counting computed tomography system, Photonova Spectra, positioning the company to launch the device across Europe and other markets that recognize the certification.
Regulatory clearance paves way for European rollout
The CE mark follows prior approvals in the United States and Japan, allowing commercial activities in the European Union, Switzerland and the United Kingdom. Acceptance of the mark can also speed entry into Australia and Singapore, where the certification is respected.
Photonova Spectra uses photon‑counting detectors that count individual X‑ray photons and measure their energy directly. By skipping the light‑conversion step used in conventional CT scanners, the system aims to reduce information loss and deliver higher‑contrast images.
Industry analysts noted that the technology’s ease of installation could give it an edge over rivals, though the market has been led by another player for several years.
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Head‑to‑head with Siemens Healthineers’ Naeotom Alpha
Siemens Healthineers introduced its Naeotom Alpha line of photon‑counting CT devices in Europe in 2021, giving it an early foothold. Those systems now account for roughly 30% of Siemens’ total CT equipment orders, according to the medtech firm’s chief executive.
GE’s entry could challenge that share, especially as hospitals evaluate the clinical benefits of photon‑counting technology. The two companies differ in sensor design, with GE having acquired Prismatic Sensors in 2020 to develop its own detector architecture.
“We expect Photonova to be a significant growth driver starting late this year,” said Peter Arduini, CEO of GE HealthCare, during an earnings call. He added that U.S. customers had shown strong interest after the Food and Drug Administration cleared the device in March.
The device contributed minimally to the second‑quarter order book, but the outlook suggests a shift as more facilities adopt the newer imaging method.
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Photonova’s performance will be further examined through partnerships with the Belgian academic medical center UZ Brussel and Denmark’s Rigshospitalet. Those collaborations will test the system in cardiology and oncology settings, where image clarity can impact diagnosis and treatment planning.
Bernd Montag, chief executive of Siemens Healthineers, highlighted the company’s growing share of the U.S. CT market, attributing it to the advantages of photon‑counting technology. His comments show the competitive pressure GE now faces as it seeks to expand its footprint.
GE HealthCare will challenge Siemens Healthineers for the global photon‑counting market.
