LifeSemantics Receives MFDS Approval for Blood Pressure Analysis Software 'CanopyMD BPAI'

LifeSemantics announced on the 16th that CanopyMD BPAI, developed as blood pressure analysis software, obtained product approval from the Ministry of Food and Drug Safety on the 8th.

LifeSemantics' blood pressure management AI solution 'CanopyMD BPAI'
[Photo by LifeSemantics]

CanopyMD BPAI is a medical artificial intelligence (AI) solution developed through the Doctor Answer 2.0 project, led by the Ministry of Science and ICT and the National IT Industry Promotion Agency (NIPA). This product was developed to support healthcare professionals in systematic blood pressure management of hypertensive patients during treatment. Utilizing a recurrent neural network (RNN) approach, whose time-series data processing performance has been verified, it provides average blood pressure information for the next four weeks based on blood pressure and pulse data measured by patients at home over eight weeks. Recently, the core technology, the ‘AI-based blood pressure prediction system using blood pressure and pulse data,’ was also patented.

Hypertension, a representative chronic disease, often goes unrecognized due to the lack of clear symptoms. If left unmanaged for a long time, it can lead to cardiovascular diseases such as stroke, necessitating active management. In particular, due to the ‘white coat effect,’ which causes differences between blood pressure measured in the clinic and at home, continuous and accurate blood pressure measurement and management in daily life are required.

Following the product approval of CanopyMD BPAI, LifeSemantics plans to conduct a prospective demonstration targeting three medical institutions, including general hospitals and tertiary hospitals, to analyze and manage future blood pressure based on blood pressure and pulse data collected at home. Scheduled to be completed by the end of this year, the study will also include clinical efficacy verification of the product and satisfaction surveys on usability centered on patients and healthcare professionals. Subsequently, the application of CanopyMD BPAI in medical settings will be reviewed in line with the product’s advancement timeline.

Hong Seung-yong, Head of the Medical Device Business Division at LifeSemantics, said, “The product approval of CanopyMD BPAI is the result of recognizing LifeSemantics’ expertise and technological capabilities, cultivated through long-term medical AI research and development.” He added, “We will not be satisfied with the product approval alone but will focus on the upcoming demonstration process and do our best to ensure that CanopyMD BPAI can be stably applied in medical settings.”