LifeSemantics' 'Cardiovascular Risk Assessment AI' Confirmatory Clinical Trial Plan Approved

LifeSemantics announced on the 9th that it has received approval from the Ministry of Food and Drug Safety for the confirmatory clinical trial plan of its cardiovascular risk (hypertension complications) assessment artificial intelligence (AI) software.

[Photo by Life Semantics]

This clinical trial will be conducted as a retrospective analysis study using blood pressure measurement data from adult hypertension patients. LifeSemantics will analyze detailed blood pressure data to assess the risk of developing atherosclerotic cardiovascular disease (ASCVD), including heart and cerebrovascular diseases, and will evaluate the effectiveness and superiority of the software as a clinical trial medical device. The trial will be conducted at Chonnam National University Hospital starting next month, involving a total of 460 cases.

Hypertension, one of the major chronic diseases in adults, can lead to various complications if left untreated for a long time. It is important to detect it early and manage it properly, as it increases the likelihood of heart and brain diseases that can threaten not only quality of life but also the patient’s life.

LifeSemantics’ medical AI solution for cardiovascular risk assessment is also being considered for combined commercialization with its self-developed blood pressure prediction AI, CanopyMD BPAI, which completed its regulatory approval application last month. This is expected to significantly contribute to establishing an effective health management system for hypertension patients, including the prevention of atherosclerotic cardiovascular disease.

Heo Eun-young, Head of the Technology Commercialization Research Center at LifeSemantics, said, “Most complications of hypertension impose a heavy economic burden on treatment, making early management urgently necessary. This ‘cardiovascular risk assessment AI’ will be of great help to patients.”

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