Arrhythmia is a condition where the heart beats abnormally fast, slow, or irregularly. Symptoms can occur intermittently or not at all, making diagnosis difficult. If arrhythmia is not properly managed, it could lead to a stroke, which occurs when blood vessels to the brain become blocked or burst, damaging the brain. Serious complications such as heart failure, where the heart cannot send blood properly, or cardiac arrest, where the heart stops completely, can occur, earning it the nickname 'heart assassin.'
Synergy AI, a domestic medical device corporation, has developed an artificial intelligence (AI) technology that can easily predict arrhythmia. Synergy AI is a medical AI company founded by Professor Shin Tae-young of the Urology Department at Ewha Womans University Mokdong Hospital in 2018. CEO Shin noted, 'In a reality where the latest AI technologies are not well-used in the medical field and the barriers to entry are high due to specialization, we found a new market, a 'blue ocean,' and aimed to create synergy in the healthcare sector by combining the expertise of AI developers and doctors, leading us to dive into the AI medical industry.'
Another frightening reason for arrhythmia is that it is difficult to diagnose. The electrocardiogram (ECG) test currently performed for arrhythmia diagnosis lasts only 10 to 15 seconds, making it easy to miss intermittent arrhythmia. While monitoring devices exist, patients find it uncomfortable to wear the devices for more than 12 hours. CEO Shin has solved this problem with AI.
Synergy AI has collected over 3 million arrhythmia clinical data points to train its AI. Instead of targeting all types of arrhythmia, it consulted with clinical doctors to select 27 arrhythmia diseases requiring treatment for training. As a result of this training, the AI accurately predicted the probability of arrhythmia occurring within 14 days at a rate of 91.7%. Starting in 2023, Synergy AI has conducted clinical trials of its arrhythmia diagnostic AI 'Mac'AI' and obtained second-class medical device approval from the Ministry of Food and Drug Safety.
CEO Shin said, 'Not all arrhythmias require treatment, so from the service planning stage, we designated arrhythmias that need treatment and simulated the clinical application stage.' He added, 'Although it was not easy to secure clinical data, we were able to gather data by approaching tertiary general hospitals and secondary hospitals in different ways.'
While AI to detect arrhythmia or heart failure has been developed before, Synergy AI has improved the predictive accuracy and increased the types of arrhythmias being predicted. 'Mac'AI' was designated as a new medical technology pending evaluation, allowing it to be prescribed through non-reimbursed services starting in January next year. Synergy AI has completed the installation of 'Mac'AI' at 10 university hospitals, including Seoul National University Hospital, Eulji University Hospital, Eunpyeong St. Mary's Hospital, and Ewha Seoul Hospital, and is preparing for official sales beginning next year. CEO Shin remarked, 'It is also possible to claim expenses through legal non-reimbursed services,' and added, 'We will enable patients to easily benefit from AI medical technology through hospital prescriptions.'
Synergy AI plans to obtain pre-market approval (510k) from the U.S. Food and Drug Administration (FDA). Alongside its entry into the U.S. market, it plans to expand services from arrhythmia prediction to include predictions of stroke and heart failure. The G-Valley Medical Device Development Support Center is supporting Synergy AI.
The G-Valley Medical Device Development Support Center, operated jointly by the Seoul Metropolitan Government, the Korea Institute of Science and Technology (KIST), and Korea University Guro Hospital, assists domestic medical device corporations in product development and overseas expansion. Synergy AI received exhibition support from the G-Valley Medical Device Development Support Center, allowing it to conduct 26 meetings with investors and clients.
A Synergy AI official said, 'We were able to connect for export-related consultations and investor meetings, and to verify our business model with the help of the G-Valley Medical Device Development Support Center.' He added, 'We also received assistance in forming networks with companies and medical institutions that can handle overseas approvals, sales, and marketing,' and explained that the G-Valley Medical Device Development Support Center also greatly aided in analyzing technology trends and establishing key patent strategies.