GE HealthCare has obtained a CE mark for its Photonova Spectra photon-counting spectral computed tomography scanner, enabling the company to begin commercial activities in countries that accept the European conformity certification. This follows earlier regulatory decisions in the United States and Japan and paves the way for the scanner’s launch in Europe.
The technology aims to improve image clarity and contrast compared with conventional computed tomography systems. Under the CE mark, the scanner can be sold in markets including the European Union, Switzerland and the United Kingdom. The certification may also shorten the path to other markets, including Australia and Singapore, according to the article.
How Does Photon-Counting Imaging Technology Differ?
Traditional CT scanners rely on detectors that convert X-rays into light before processing the signal. Photon-counting technology, by contrast, measures X-ray photons directly and determines the energy of each photon. GE HealthCare believes that removing the intermediate conversion step may reduce information loss and produce images that are more useful to physicians.
The CE mark alone does not establish comprehensive clinical superiority over all existing imaging systems; it opens the regulatory and commercial path in the relevant markets. Real-world use and clinical evaluations will help determine the device’s practical value in different fields.
Direct Competition with Siemens Healthineers
With this scanner, GE HealthCare is entering a market in which Siemens Healthineers has already established a presence. Siemens Healthineers’ Naeotom Alpha scanners received their first approvals for use in Europe in 2021. GE had acquired Prismatic Sensors in 2020, betting on the sensing technology required for photon-counting CT.
According to Citi Research analysts cited by the article, Photonova may stand out for its ease of installation and sensor technology, despite GE HealthCare’s late entry into the market compared with its rival. The competition is particularly significant because Bernd Montag, CEO of Siemens Healthineers, said on an earnings call in July that photon-counting scanners represented about 30% of the company’s total CT-equipment order volumes.
What Happens After Approval?
GE HealthCare has expanded its collaboration with the Belgian academic medical center UZ Brussel and the Danish university hospital Rigshospitalet to evaluate Photonova in therapeutic areas including cardiology and oncology. These partnerships provide a practical test of the technology beyond the regulatory-approval stage.
In the United States, the company said customers had shown “strong interest” in the scanner after it received Food and Drug Administration clearance in March. However, CEO Peter Arduini described the scanner’s contribution to the order book during the second quarter as “limited,” while expecting it to become a “meaningful” growth driver starting late this year.
Editorial reading: The actual change is Photonova’s transition from the development and approval stage to multi-market commercial expansion. However, the volume of future orders, the speed of hospital adoption and the results emerging from GE HealthCare’s collaboration with medical centers will determine whether ease of installation and sensor technology are sufficient to narrow the gap with Siemens Healthineers.