The growth of leading domestic companies in the medical AI field is becoming evident, as the number of clinical trial applications, approvals, and authorizations rapidly increases. Medical AI involves AI trained on various disease data, analyzing patients’ Computed Tomography (CT) scans or Magnetic Resonance Imaging (MRI), among others, to assist in the diagnosis and prediction of various diseases.
According to the Ministry of Food and Drug Safety on March 18, the number of approved clinical trial plans for AI-based software medical devices (hereafter referred to as medical AI) recorded a maximum of 59 cases last year, gradually increasing from 4 cases in 2018 to 16 in 2019 and 31 in 2022.
The number of approvals, certifications, and notifications also increased from 4 cases in 2018 to 13 in 2019, 50 in 2020, and 62 last year.
This trend is interpreted as a result of the leading medical AI companies, such as Lunit and Vuno, speeding up development as their products have led to actual performance, encouraging later entrants to accelerate their development efforts as well.
After DeepBio, a domestic medical device company, obtained in April 2020 the country’s first approval for prostate cancer diagnostic assistant software, other companies also embarked on developing AI for assisting in the diagnosis of acute stroke occurrence and location, detecting pancreatic cancer regions in ultrasound images, and predicting myocardial infarction risks in cardiovascular patients.
New entrants mainly focus on developing solutions for disease areas not previously covered by leading companies.
LifeSemantics, a digital health company based on AI, on March 18 applied for product approval to the Ministry of Food and Drug Safety for a hair density analysis AI solution “canofy MD HDAI.” By capturing scalp images with a smartphone, the AI measures the number of hair follicles and the number of hairs that can be transplanted, aiding in the treatment of hair loss. The company has also recently applied for product approval for their blood pressure prediction AI solution “canofy MD BPAI” and a skin cancer diagnostic assistant medical AI solution “canofy MD SCAI.”
Another medical AI company, JLK, has focused on the stroke field, owning solutions such as “JBS-04K” for detecting cerebral hemorrhage and “JBS-01K” for classifying types of cerebral infarction.
Corelinesoft is concentrating on lung diseases with its lung cancer, emphysema, and coronary artery disease diagnostic assistant solutions “Aview LCS” and “Aview LCS Plus.”