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Home » Brightonix wins FDA nod for flagship PET imaging system

Brightonix wins FDA nod for flagship PET imaging system

August 26, 2025 By Sean Whooley

Brightonix Imaging Pharos PET Scanner (1)
The Pharos PET imaging system. [Image courtesy of Brightonix]

Brightonix Imaging announced today that its flagship Pharos positron emission tomography (PET) scanner received FDA clearance.

Pharos, a state-of-the-art clinical PET system, offers high-quality imaging as part of a tool for early disease detection, precise diagnosis and optimized treatment planning. The Seoul, South Korea-based company says it ushers in a new era of precision and efficiency in nuclear imaging.

Brightonix developed Pharos with an innovative design and enhanced performance capabilities, it said in a news release. It hopes for the system to set new standards in neurology, in particular. Pharos also features multi-functionality as it can physically orient the patient seat and detector configurations for extremity and breast imaging. It can also convert to both lying and seated modes for brain imaging.

Features of Pharos include advanced detector technology for high-resolution imaging. Its compact, space-efficient footprint enables easier installation in a wide range of clinical environments. The system’s multi-functionality allows for tailored configurations for brain, breast and extremity PET scans. Meanwhile, Pharos has an intuitive interface and streamlined workflow for easy operation by clinicians and technologists.

“Receiving FDA clearance for the PHAROS PET Scanner is a monumental achievement for us and for the entire medical imaging community. 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,” said Jae Sung Lee, CEO and founder of Brightonix Imaging.

Filed Under: 510(k), Food & Drug Administration (FDA), Health Technology, Imaging, Regulatory/Compliance Tagged With: Brightonix Imaging

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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