Medical artificial intelligence (AI) company Promedius (CEO Seong-Hyeon Jeong) announced on the 10th that it has received domestic approval from the Ministry of Food and Drug Safety for its osteoporosis diagnosis assistance AI software, 'PROS® CXR: OSTEO'.
PROS® CXR: OSTEO is an AI software that screens for osteoporosis based on chest X-ray images and assists medical staff in their diagnosis. It detects osteoporosis through easily accessible chest X-rays and assists medical staff in their diagnosis.
Osteoporosis is difficult to diagnose early because there are no early symptoms, and if the disease progresses, it can lead to fractures and cause serious health problems. In particular, osteoporotic fractures not only lower the patient's quality of life, but are also dangerous diseases with a mortality rate of 20-30% within one year after occurrence. Hip and spinal fractures are identified as the main cause of increased medical expenses among the elderly, and they are emerging as an even more important issue in the rapidly aging domestic medical environment.
PROS® CXR: OSTEO is an AI solution that screens for osteoporosis based on X-ray images to solve these problems and assists medical professionals in their diagnosis. It is less expensive than the existing bone density test, DXA (dual-energy X-ray absorptiometry), and has a lower risk of radiation exposure than the QCT (volumetric bone density) test. In addition, it is highly accessible because it is based on X-ray, which is the most widely used in the medical field. The PROS® CXR: OSTEO AI model was introduced in JBMR, an academic journal of the American Society for Bone and Mineral Research (ASBMR), and demonstrated high accuracy in identifying osteoporosis patients.
Meanwhile, PROS® CXR: OSTEO was already designated as the first innovative medical device in the osteoporosis field by the Ministry of Food and Drug Safety in November of last year. In addition to this manufacturing approval, Promedius plans to further accelerate marketing for entry into the domestic medical field and expand its presence in domestic and international markets.
Jeong Seong-hyeon, CEO of Promedius, said, “This product will help prevent the risk of fractures by screening osteoporosis patients early and providing treatment opportunities,” adding, “We expect rapid market entry and sales expansion as we have gone through a thorough research and verification process to commercialize the product.”
He added, “We expect that in the third quarter of this year, it will be possible for patients to file non-covered claims by utilizing the new medical technology assessment deferral track.”
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