LifeSemantics Begins Confirmatory Clinical Trial for Home Blood Pressure Prediction Software

Digital health specialist LifeSemantics announced on the 6th that it has commenced a confirmatory clinical trial for its 'Home Blood Pressure Prediction Software (SW)'.

Life Semantics Office Building Exterior [Photo by Life Semantics]

This clinical trial follows the approval of the confirmatory clinical trial plan by the Ministry of Food and Drug Safety in May, which classified the software as a Class 2 medical device for blood pressure analysis software. The trial will be conducted at Chonnam National University Hospital, Bucheon St. Mary's Hospital, and Hanyang University Hospital, targeting approximately 160 hypertension patients.

The home blood pressure prediction software developed by LifeSemantics through the Dr.Answer 2.0 project is a medical artificial intelligence (AI) software designed to assist in the treatment and management planning of hypertension patients. When patients record their blood pressure via a mobile application for home blood pressure monitoring over eight weeks, the software predicts blood pressure 1 to 4 weeks ahead based on clinical data, providing integrated information that can be used for identifying high-risk hypertension groups and managing medication dosages, thereby aiding patient treatment plans.

According to the Chronic Disease Health Statistics from the Korea Disease Control and Prevention Agency, the prevalence of hypertension in South Korea was 28.3% as of 2020, and it is expected to continue increasing due to population aging. Hypertension, recognized as a representative chronic disease, poses a risk of cerebrovascular diseases such as cerebral infarction and cerebral hemorrhage if not properly managed, necessitating active prevention and management. However, blood pressure measured in hospitals can be elevated due to tension and other factors, a phenomenon known as 'white coat hypertension,' making patient-led home blood pressure measurement critically important.

LifeSemantics expects that once the safety and efficacy of the home blood pressure prediction software are verified through this confirmatory clinical trial, patients will be able to routinely measure their blood pressure at home in daily life and utilize self-measured values in hospital consultations, enabling personalized treatment.

Kim Eunghee, head of the Research and Development team at LifeSemantics, stated, “It is particularly meaningful that the home blood pressure prediction software, developed as a key task of the medical AI business since 2021, has now entered the confirmatory clinical trial phase. We will strive to successfully complete the clinical and validation processes and commercialize the software so that LifeSemantics’ medical AI software can contribute to the advancement of healthcare technology.”

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