Coreline Soft Obtains Approval for 'Pulmonary Embolism Diagnosis Assistance' Solution

Medical AI company Coreline Soft announced on the 13th that it recently obtained medical device manufacturing certification (pre-market approval) for its AI solution Aview PE.

Coreline Soft's AI software for assisting pulmonary embolism diagnosis, 'Aview PE'
[Photo by Coreline Soft]

Aview PE is software that automatically detects pulmonary embolism based on AI and assists in diagnosis. Pulmonary embolism is a condition where the pulmonary artery is blocked, causing the lungs to malfunction. If not treated promptly, the mortality rate can reach 30%, but with appropriate anticoagulant treatment, the mortality rate decreases to 2-8%, making rapid diagnosis and intervention crucial. Acute pulmonary embolism particularly occurs frequently in hospitalized patients, elderly patients, and cancer patients, and the number of patients is increasing along with the rise in underlying diseases.

In the United States, the largest medical market, AI software assisting pulmonary embolism diagnosis has been released, and numerous studies on its clinical efficacy have been published in many hospitals. However, while those products only notify medical staff of patients suspected of pulmonary embolism, Coreline Soft’s Aview PE has the distinctive feature of directly marking the suspected areas of pulmonary embolism, enabling medical staff to identify the location of the embolism. Based on this feature, Aview PE was designated as the first innovative medical device in Korea in the pulmonary embolism diagnosis assistance category last June.

Junmin Park, Chief Product Officer (CPO) of Coreline Soft, explained, “Emergency rooms often exceed available bed capacity or have multiple critically ill patients, creating overcrowded situations where medical staff find it difficult to immediately interpret imaging results. Aview can send alerts to medical staff through various methods as soon as abnormal findings are detected in three critical diseases, enabling early diagnosis and treatment of patients.”

Coreline Soft plans to expand the market presence of Aview PE by receiving reimbursement for three years as an innovative medical technology, while simultaneously proving the product’s clinical efficacy. Following this, the company aims to officially register the product with the National Health Insurance according to subsequent procedures.