Brightonix Imaging Nabs FDA Clearance for its PHAROS PET Scanner

The U.S. Food and Drug Administration has cleared Brightonix Imaging’s flagship product, the PHAROS PET Scanner, a state-of-the art clinical positron emission tomography (PET) system that offers healthcare providers a powerful tool for early disease detection, precise diagnosis, and optimized treatment planning.

PHAROS is multi-functional with the ability to physically orient the patient seat and detector configurations for extremity and breast imaging, as well as converting to both lying and seated modes for brain imaging.

The PHAROS PET Scanner’s key features and benefits include:

• Unprecedented image clarity: Using advanced detector technology, the PHAROS PET Scanner delivers high-resolution images, enabling clinicians to visualize even the most subtle anomalies for accurate diagnosis and treatment.
• Compact footprint: The PHAROS scanner is designed with a space-efficient footprint, enabling easier installation in a wide range of clinical environments. Its streamlined design provides greater flexibility for hospitals and imaging centers with limited space, without compromising imaging performance.
• Flexible applications: Its multifunctionality allows tailored configurations for brain, breast, and extremity PET scans, while offering a more comfortable setup that enhances the overall patient experience.
• User-friendly interface: Featuring an intuitive interface and streamlined workflow, the PHAROS PET Scanner is designed to be easily operated by clinicians and technologists, enhancing user experience and ensuring seamless integration into medical practices.

“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,” Brightonix Imaging Founder/CEO Prof. Jae Sung Lee said.

PHAROS’s development was supported by the Korea Medical Device Development Fund (KMDF), reflecting a collaborative effort across multiple government agencies to advance innovative medical imaging technologies.

Having secured FDA clearance, Brightonix Imaging now will begin rolling out the PHAROS PET Scanner to U.S. medical facilities.

Founded with a commitment to innovation and excellence in medical imaging, Brightonix Imaging develops cutting-edge solutions that enhance diagnostic accuracy, patient care, and overall clinical performance. The company’s portfolio includes advanced clinical PET, medical artificial intellilgence software and preclinical PET/CT imaging systems.