Brightonix Imaging has received clearance from the U.S. Food and Drug Administration for its PHAROS PET scanner, opening the door for the Seoul, South Korea-based company to begin U.S. distribution.

PHAROS is a clinical PET system designed for high-resolution imaging with a compact footprint and modular configuration. The system supports brain, extremity, and breast scans, and offers both seated and lying-down modes for brain imaging.

The FDA decision follows development efforts partially funded by the Korea Medical Device Development Fund, a multi-agency initiative supporting the advancement of medical technology.
“Receiving FDA clearance for the PHAROS PET Scanner is a monumental achievement for us and for the entire medical imaging community,” said professor Jae Sung Lee, CEO and founder of Brightonix Imaging. “This technology will empower healthcare providers with the tools to detect and treat neurodegenerative diseases earlier and with greater precision, ultimately improving patient outcomes.”

The system’s design allows clinicians to reconfigure the scanner for different anatomical targets. Brightonix also highlights a simplified user interface and smaller footprint aimed at easing adoption in space-constrained facilities.

Founded with a focus on diagnostic imaging, Brightonix Imaging develops clinical and preclinical PET and PET/CT systems, along with AI software for imaging applications.

With regulatory approval in place, Brightonix plans to begin commercial deployment of the PHAROS system to hospitals and imaging centers across the United States.

Molecular Imaging Homepage