The Ministry of Food and Drug Safety said Wednesday that it has approved VUNOmed-BoneAge, an AI-based medical device.
The equipment, developed by VUNO, is the first AI-based equipment certified by the government. The device determines a patient's bone age by recognizing patterns on an X-ray image and marking its similarities with 58 standard reference images -- 31 males and 27 females. Combined with hormone levels and other information, doctors can use the machine’s information to diagnose precocious puberty and slow growth
The company has proved the efficacy of the system after a clinical trial. The test showed that the AI device and doctors had an average difference rate of 0.9 months. However, the manufacturer has designed the equipment to update images and learn from them periodically, which in turn will narrow the gap with doctors.
Both the company and the ministry expect the invention will shorten the reading time by automating the manual reading of the bone age. Conventionally, doctors had to compare the patient's left-hand X-ray image with the reference standard image (GP).
The ministry noted that three more products are undergoing clinical trials in line with the “Authorization of medical devices with Big Data and AI technology” guidelines put into effect last year.
Other systems include magnetic resonance imaging software for classifying cerebral infarcts and two devices that aim to aid in pulmonary nodules diagnosis through X-ray imaging.
“The ministry has launched projects such as the ‘Next Generation 100 Project’ and ‘Newly Developed Medical Device License Assistant’ that assist all regulatory processes from product research, development, clinical trials and licenses,” the ministry said. “We expect that the new procedures will support the rapid development of medical devices related to the Fourth Industrial Revolution such as artificial intelligence, virtual reality and 3D printing.”
The government will continue to support the development of advanced medical devices actively, the ministry added.
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