Dive Brief:
- GE HealthCare said Monday it received a CE mark for its spectral photon-counting computed tomography, or CT, device, Photonova Spectra.
- The CE mark, which follows regulatory decisions in the U.S. and Japan, positions GE HealthCare to start the European launch of technology designed to provide a sharper, higher-contrast image.
- Photonova will compete with Siemens Healthineers’ Naeotom Alpha imaging devices, a line of photon-counting CT products first cleared for use in Europe in 2021.
Dive Insight:
Unlike standard CT detectors, photon-counting technology creates images without converting X-rays into light. Rather, machines such as Photonova count X-ray photons and individually measure their energy. The elimination of the intermediate light-conversion step could minimize information loss, resulting in an image that is more useful to physicians.
GE HealthCare bet on that idea when it bought Prismatic Sensors in 2020. While the company ceded a head start to Siemens Healthineers, Citi Research analysts noted in March that Photonova’s ease of installation and sensor technology could differentiate GE HealthCare’s device.
Having received a CE mark, GE HealthCare will start commercial activities in countries that accept the conformity certification. CE marks are accepted in markets including the European Union, Switzerland and the U.K. and can shorten the path to market in countries including Australia and Singapore.
To further evaluate Photonova, GE HealthCare has expanded collaborations with the Belgian academic medical center UZ Brussel and the Danish university hospital Rigshospitalet. The collaborators will assess the technology in therapeutic areas including cardiology and oncology.
U.S. customers showed “strong interest” in Photonova after the Food and Drug Administration cleared the device in March, GE HealthCare CEO Peter Arduini said on an earnings call in July. The device was “a minimal contributor” to the order book in the second quarter, Arduini said, but is expected to be “a significant growth driver” starting late this year.
GE HealthCare will challenge Siemens Healthineers for the global photon-counting market. Photon-counting devices account for about 30% of Siemens Healthineers’ total CT equipment order volumes, Bernd Montag, CEO of the European medtech company, said on an earnings call in July. Montag attributed Siemens Healthineers’ growing share of the U.S. CT market to the technology.
