AI Mobile C-arm PROVUE Wins MFDS Approval

Full-scale Global Launch to Begin in the Second Half of the Year

  • Development of a denoising algorithm based on joint research with KAIST, reducing the radiation exposure burden on medical staff and patients
  • Pushing for a global launch in the second half of this year, expanding the mobile diagnostic imaging equipment portfolio

DRGEM recently obtained MFDS manufacturing certification for our new PROVUE Mobile C-arm (X-ray fluoroscopy system). This key approval officially validates our advanced AI-based low-dose imaging technology.

We proudly announce that this certification covers three models: PROVUE-5S, PROVUE-15S, and PROVUE-5A. The medical device fully complies with all regulatory safety and quality requirements. This official recognition lays a solid foundation for our expansion into both domestic and global markets.

Development of a denoising algorithm based on joint research with KAIST

During surgical procedures, a mobile C-arm system uses X-rays in real time. Therefore, the system must minimize radiation exposure while delivering clear images. DRGEM applied a powerful AI-based imaging engine to the PROVUE Mobile C-arm. This engine enables real-time fluoroscopic imaging even in low voltage and low current environments. This technology reduces the radiation burden on medical staff and patients. At the same time, it ensures excellent image quality for accurate diagnosis.

Specifically, we applied a new denoising algorithm developed through joint research with KAIST. This algorithm effectively removes image noise during low-dose imaging. It lowers the total radiation dose while delivering crisp, clear X-ray images. This breakthrough will strengthen our technological leadership in the fluoroscopy market.

Leaping Forward into the Global Healthcare Market

The domestic manufacturing certification of the PROVUE Mobile C-arm is a meaningful milestone. This achievement proves DRGEM’s advanced image processing technology and strong market competitiveness once again. Building on this success, we are now accelerating mass production preparations to officially showcase the system to the global market in the second half of 2026.

Through continuous research and quality innovation, we will provide safer, more reliable medical imaging solutions worldwide. Starting with the PROVUE Mobile C-arm, we will continuously expand our next-generation diagnostic product portfolio to further enhance our competitiveness in the global market.

Share the Post:

Related Posts