Compact multifunctional PET scanner receives clearance in the US

A new multifunctional PET imaging system was just cleared for use in the United States by the U.S. Food and Drug Administration. 

South Korea-based Brightonix Imaging—a company that specializes in imaging and artificial intelligence solutions—announced the clearance of its Pharos PET Scanner on Aug. 26. The machine was built with patients in mind, and its compact design has the potential to expand access to the modality where it may have previously been lacking. 

"Receiving FDA clearance for the PHAROS PET Scanner is a monumental achievement for us and for the entire medical imaging community,” Professor Jae Sung Lee, CEO and Founder of Brightonix Imaging, said in an announcement. “This technology will empower healthcare providers with the tools to detect and treat neuro degenerative diseases earlier and with greater precision, ultimately improving patient outcomes." 

Subscribe to Radiology Business News

The PET system can accommodate a multitude of patients due to its multipositional capabilities. Patients can undergo their scans both sitting and lying down. This enables providers to routinely utilize the machine to image the breast, extremities, brain, chest and torso. 

Its compact size also is a notable feature. The Pharos scanner is smaller than most PET systems, enabling organizations that may have previously had limited PET options due to size to install the system without changing their infrastructure. 

The clearance comes as the demand for PET imaging in the U.S. has risen significantly in recent years. In 2024, market research firm IMV reported that PET volumes in the U.S. rose by nearly 13% compared to the year prior; that increase followed a more than 10% uptick reported in 2023. 

Now that the scanner has overcome regulatory hurdles, Brightonix is planning to ramp up production to meet demand in the U.S. Interested parties can learn more about the new PET system here. 

Hannah Murphy
Hannah Murphy, Editor

In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.

Subscribe to Radiology Business News

Subscribe to Radiology Business News