Development Achievements Incorporating AI – Introducing Buzzpole Service Clinic [View Original]

Results in the development of medical devices incorporating AI are beginning to emerge.

Last year, the first clinical trial for a medical device using artificial intelligence (AI) technology was approved in Korea. According to the Ministry of Food and Drug Safety's "2017 Medical Device Clinical Trial Plan Approval Status Analysis," 84 medical device clinical trial plans were approved last year. Three of these were clinical trials using AI technology.

The three approved clinical trials involved software for classifying cerebral infarction types, software for measuring bone age in growing children, and software for diagnosing pulmonary nodules using X-ray images. Other medical devices utilizing Fourth Industrial Revolution technologies included an artificial cheekbone that can reconstruct damaged cheekbones using 3D printing, and a brain electrical stimulation device for psychotherapy that helps treat dementia through electrical stimulation.

Meanwhile, by medical device type, 43 devices and machinery, including personal low-frequency stimulators, 25 medical supplies, including wound dressings, and 16 in vitro diagnostic medical devices, including genetic disease testing reagents, were approved. While the number of clinical trials for in vitro diagnostic medical devices decreased from 39 in 2015 and 56 in 2016 to 16 last year, immunoassay reagents, which use skin, mucosa, and tissue samples to diagnose HIV and hepatitis C, continued to be conducted, with six in 2015, seven in 2016, and seven in 2017. Tumor-related genetic testing reagents, which detect cancers like lung cancer early, also increased from three in 2015 to seven last year.

The Ministry of Food and Drug Safety (MFDS) announced, "We plan to continue improving clinical trial-related systems to facilitate active medical device research and development through clinical trials, while also strengthening the management of clinical trial institutions and the safety of clinical trial participants."

On the 11th (local time), the U.S. Food and Drug Administration (FDA) announced that it had approved the "IDx-DR," a medical device for diagnosing diabetic retinopathy.

This marks the first FDA approval for IDx-DR, developed by IDx, a company specializing in AI-based diagnostic devices.

IDx-DR is a software program that uses AI algorithms to analyze images of the eye taken with a fundus camera called the "Topcon NW400." The software is used by doctors uploading digital images of the patient's retina to a cloud server equipped with the "IDx-DR" software.

In Korea, Buzzpole's AI-powered remote cervical cancer screening system, Cerviclinic A.I., is set to be exported to Canada and China. Cerviclinic A.I. connects patients in underserved areas with specialists in major cities. Its CDSS (Clinical Decision Support System) uses AI to provide preliminary filtering of patient lesions between specialists.

An industry insider stated, "AI is expected to advance further in the medical device sector. The data from the initial analysis of patient lesions by AI will assist doctors in making a final diagnosis."

April 17, 2018, 4:16 PM / Sports Kyunghyang / Reporter Kim Moon-seok kmseok@kyunghyang.com