The Ministry of Food and Drug Safety has approved the first artificial intelligence-based in vitro diagnostic software, DeepDx-Prostate, on Friday.
DeepDx-Prostate, developed by DeepBio, a company specializing in prostate cancer diagnosis software, is a medical device that helps to diagnose prostate cancer by learning its images through AI, the ministry said in a news release.
Prostate cancer is usually diagnosed by a pathologist who dyes the prostate tissue and then observes and analyzes it under a microscope. However, DeepDx-Prostate analyzes the dyed tissue image to find the presence or absence of prostate cancer tissue and helps the medical practitioners’ job.
DeepDx-Prostate is likely to be highly useful as a supplement in the medical field as it has shown 98.5 percent sensitivity and 92.9 specificity compared to the results of pathologists with more than five years of experience in clinical trials.
Sensitivity refers to the proportion of patients with a positive response in the target group with the disease, and specificity means the proportion of patients with a negative test result in the target group without the disease.
The ministry is helping the domestic companies win approvals rapidly by providing technical information, such as clinical trial planning and efficacy evaluation methods, to them through consulting at product briefing sessions.
Since approving AI-based medical devices developed to read the patient's bone age in Korea the first time in May 2018, the ministry has given the go-ahead to 20 products developed by 11 companies on the fast-track approval basis, according to the news release.
In the fourth industrial revolution, AI-based product development in the field of in vitro diagnostic devices is likely to become more active, and the ministry will continue to support the rapid commercialization of Korean medical devices, it added.
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