Brightonix Imaging Obtains Medical Device Manufacturing Certification for Korea's First Developed Clinical PET System
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- 2024-02-19
Brightonix Imaging Obtains Medical Device Manufacturing Certification
for Korea's First Developed Clinical PET System
 ▲ PHAROS |
'PHAROS', the first clinical positron emission tomography (PET) system developed by deep-tech startup Brightonix Imaging (Jae Sung Lee, CEO) in Korea, received a medical device manufacturing certificate from the Korea's National Institute of Medical Device Safety Information on February 13th.
'PHAROS' is a versatile and multifunctional digital PET system that allows brain imaging in the sitting or supine position and breast imaging in the prone position. It can be installed and operated in a smaller space compared to conventional whole-body PET/CT. Brain PET scans are expected to play a major role in the early detection and treatment of brain diseases, especially as the incidence of degenerative brain diseases is increasing due to the aging population, and the U.S. FDA's accelerated approval of Biogen's Leqembi and Eli Lilly's successful Phase III clinical trial of Donanemab.
'PHAROS' has been developed with close support from Korea Medical Device Development Fund, where streamlined the entire process from product development to regulatory approval. Recognized for its forward-looking feaures and high potential for future advancements in the medical device field, it has garnered significant attention from both the market and the industry, earning recognition as one of the top 10 representative achievements by the KMDF team.
Brightonix Imaging's CEO, Jae Sung Lee, expressed significant meaning in obtaining the medical device manufacturing certification for the 'PHAROS' system. He emphasized that this achievement, marking the first domestically produced clinical PET system to receive medical device manufacturing certification, is the result of the dedicated efforts of many researchers working towards the localization of PET systems, along with continuous support from the government. Lee stated, "This milestone holds great significance, as it signifies the culmination of valuable efforts. Moving forward, we aim not only to penetrate the domestic market but also to showcase the excellence of domestically produced medical devices on the global stage through FDA/CE certifications."
In addition, Dr. Guen Bae Ko, CTO of Brightonix Imaging explained, "'PHAROS' has achieved a revolutionary improvement in the spatial resolution uniformity of PET images by precisely measuring gamma-ray reaction depth information within the scintillation crystal, a feature not provided by conventional whole-body PET/CT systems. With a specialized design for local organs such as the brain, it will minimize patient radiation exposure, enabling more efficient and accurate diagnoses."