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Development achievements using artificial intelligence – Introduction of Buzzpole 'Cerviclinic'

Results of medical device development using artificial intelligence have begun to appear.

Last year, Korea approved the first clinical trial of a medical device using artificial intelligence (AI) technology. According to the Ministry of Food and Drug Safety’s ‘2017 Medical 

Device Clinical Trial Plan Approval Status Analysis’, the number of approvals for clinical trial plans for medical devices was 84 in last year. Three of them were clinical trials of medical devices with AI technology.

The three approved clinical trials were software to classify types of cerebral infarction, software to measure bone age in growing children, and software to help diagnose lung nodules through X-ray images. Other medical devices with technologies related to the 4th industry include artificial cheekbones that can rebuild damaged cheekbones through 3D printing, and brain electrical stimulation devices for psychotherapy that help treat dementia through electrical stimulation.

Meanwhile, by type of medical device, 43 devices and machinery such as personal low-frequency stimulators, 25 cases of medical supplies such as wound dressings, and 16 cases of in vitro diagnostic medical devices such as genetic disease test reagents were approved. In the case of in vitro diagnostic medical devices, the number of clinical trials decreased 

from 39 in 2015 and 56 in 2016 to 16 last year. Immunotest reagents for diagnosing AIDS (HIV) and hepatitis C (HCV) by collecting skin mucous membranes and tissues have been 

steadily conducted, with 6 cases in 2015, 7 cases in 2016, and 7 cases in 2017. The number of tumor-related genetic test reagents that detect cancers such as lung cancer at an early stage is also increasing from 3 cases in 2015 to 7 cases last year.

The Ministry of Food and Drug Safety said, "We plan to improve the clinical trial-related system so that research and development of medical devices can be actively conducted 

through clinical trials in the future, and at the same time, we will strengthen the safety of clinical trial participants as well as the management of clinical trial institutions."

On 11th of April, the U.S. Food and Drug Administration (FDA) announced that it had approved IDx-DR, a medical device to diagnose diabetic retinopathy.

This is the first time to approved by the FDA. IDx-DR from IDx is a company specializing in artificial intelligence-based diagnostic devices.

IDx-DR is a software program that uses artificial intelligence algorithms to analyze eye images taken with a fundus camera called Topcon NW400. It is used by a doctor uploading a 

digital image taken of the patient's retina to a cloud server where 'IDx-DR' software is installed.

In Korea, Cerviclinic A.I., an artificial intelligence cervical cancer remote diagnosis system developed by Buzzpole, is set to be exported to Canada and China. Cerviclinic A.I. is a 

remote reading system that connects patients in areas with underdeveloped medical infrastructure with specialists in large cities. It is a CDSS (Clinical Decision Support System) 

that filters patients' lesions through artificial intelligence between specialists before doctor.

An official of Buzzpole said, “Artificial intelligence is likely to advance further in the field of medical devices. Data from the primary analysis of the patient’s lesions by artificial 

intelligence will help doctors make a final diagnosis.”

17th. Apr. 2018. 16:16 / Sports Kyunghyang / Reporter Kim Moon-seok Kim kmseok@kyunghyang.com