"From Bone Age Diagnosis to Depression Treatment"…Rapid Growth in Software Medical Device Development

MFDS Approves 91 Clinical Trials for Digital Therapeutics and More
114 Products Authorized from 2018 to Present

VUNO's 'Medical Imaging Analysis Software,' the first AI-based software medical device approved in Korea. It analyzes the patient's left hand X-ray images, enabling medical professionals to assess the patient's bone age.

[Asia Economy Reporter Jo In-kyung] Software medical devices are being actively developed in various fields, ranging from video detection and diagnostic assistance to treatment. Since 2013, a total of 91 clinical trials have been approved, and 114 items have been authorized.

According to the Ministry of Food and Drug Safety on the 18th, the number of domestic software medical device approvals has reached a total of 114 as of the 14th of this month, starting with VUNO's artificial intelligence (AI)-based diagnostic assistance software in May 2018.

Software medical devices refer to medical devices developed and manufactured solely with software that have been approved, certified, or reported. Initially, these products started as medical imaging analysis tools to assist medical professionals in diagnosis, but later evolved by applying AI technology to achieve higher sensitivity and specificity. Currently, various AI-based medical devices that analyze not only medical images but also biosignals and pathological tissues, and assist in establishing patient treatment plans, have been approved and are in use in medical settings.

In diagnostic assistance, representative examples include products that analyze cerebral computed tomography (CT) images to help diagnose vascular occlusion, or analyze cervical colposcopy images to assist in diagnosing cervical cancer. The Ministry of Food and Drug Safety operates an 'Innovative Medical Device' system to support the development of new products applying advanced technology, and among the 19 designated products so far, 11 are AI-applied software medical devices that assist in disease diagnosis.

Recently, software medical device development has also been progressing in the fields of 'prevention and treatment' of mild mental illnesses such as depression, and 'disease prediction' by analyzing biosignals to predict disease occurrence in the short term. In the prevention and treatment field, products have been developed that induce lifestyle and cognitive improvements to alleviate symptoms of insomnia patients, use virtual reality technology to assess and prevent suicide risk in depression patients, and induce lifestyle changes to improve nicotine dependence symptoms and related mental and behavioral disorders.

In disease prediction, products under development include those that predict the possibility of recurrence within two years based on clinical information and chest CT images of non-small cell lung cancer patients who underwent specific procedures, and those that analyze electronic medical record data such as systolic and diastolic blood pressure, heart rate, respiratory rate, and body temperature of general ward inpatients to predict the occurrence of acute cardiac arrest.

Clinical trials to prove the performance and effectiveness of such software medical devices have steadily increased since the first approval in 2013, reaching a total of 91 to date. From 2013 to 2017, there were 7 trials, 6 in 2018, 17 in 2019, 21 in 2020, 26 in 2021, and already 14 approvals by May this year.

The Ministry of Food and Drug Safety stated, "We will continuously provide useful information to the industry, such as clinical trial and product approval status, to ensure that software medical devices, including digital therapeutics, which are core to the digital healthcare field, can be rapidly commercialized. We will also actively improve medical device-related regulations based on scientific knowledge and expertise."

This content was produced with the assistance of AI translation services.