LifeSemantics gets nod for clinical trial of cardiovascular risk assessment AI

LifeSemantics said Tuesday that it has received approval from the Ministry of Food and Drug Safety (MFDS) to conduct a confirmatory clinical trial of its cardiovascular risk (hypertension complications) assessment AI software.

The clinical trial will be a retrospective analytical study utilizing blood pressure measurement data from adult hypertensive patients.

LifeSemantics said it would analyze detailed blood pressure data to determine the risk of developing cardiac and cerebrovascular events in arteriosclerotic cardiovascular disease (ASCVD) and to validate the efficacy and superiority of its investigational medical device software.

The trial will be conducted at Chonnam National University Hospital starting May with 460 cases.

LifeSemantics is also considering commercializing the combined medical AI solution “Cardiovascular Risk Assessment AI” and its self-developed blood pressure prediction AI “Canofy MD BPAI,” which completed the license application last month.

The company expects Cardiovascular Risk Assessment AI to contribute to establishing an effective health management system for hypertensive patients by preventing atherosclerotic cardiovascular disease in the future.

"As most of the complications of hypertension have a high economic burden on treatment and early management is urgently needed, the Cardiovascular Risk Assessment AI will greatly help patients," said Heo Eun-young, head of the Technology Commercialization Research Center at LifeSemantics. "We will do our best to enhance the competitiveness of our medical AI software through product advancements, including the combined commercialization with Canofy MD BPAI, and help the medical field."