Coreline Soft's 'Aview PE' Designated as Innovative Integrated Medical Device

Coreline Soft's AI-based pulmonary embolism automatic detection and diagnostic assistance software, AviewPE, has been designated as an innovative medical device.

Coreline Soft's AI-based software for automatic detection and diagnostic assistance of pulmonary embolism, 'AviewPE'
[Photo by Coreline Soft]

Coreline Soft announced on the 27th that AviewPE was designated as the 68th innovative medical device through the integrated review of the Ministry of Food and Drug Safety on the 26th. With this designation, AviewPE can be supplied to clinical practice for at least three years under preliminary or selective reimbursement to establish clinical evidence such as efficacy. Afterwards, if it successfully passes another new medical technology evaluation and is officially registered with the National Health Insurance, it will qualify for product supply through insurance reimbursement.

AviewPE is a software medical device that automatically detects pulmonary embolism and assists diagnosis based on AI. It is the first domestic product to be designated as an innovative medical device in the pulmonary embolism diagnostic assistance category. Coreline Soft now holds the largest number of innovative integrated medical devices in the emergency medical solution field in Korea, in addition to previously designated innovative medical devices for brain hemorrhage and aortic dissection diagnostic assistance products.

Pulmonary embolism is a disease in which the pulmonary artery is blocked, causing the lungs to malfunction. If untreated, the mortality rate reaches 30%, but with appropriate anticoagulant treatment, the mortality rate decreases to 2-8%, making rapid diagnosis and intervention crucial. Acute pulmonary embolism especially 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, pulmonary embolism diagnostic assistance AI software has been released, and numerous studies on clinical efficacy have been published in many hospitals. However, unlike the products currently released in the U.S., which only notify medical staff of patients suspected of pulmonary embolism, AviewPE differentiates itself by directly marking the suspected pulmonary embolism areas, allowing medical staff to identify the location of the embolism.

Junmin Park, Chief Product Officer (CPO) of Coreline Soft and an emergency medicine specialist, said, "With this designation as an innovative medical device, AviewPE will be rapidly distributed in the emergency care field, assisting in the swift and accurate diagnosis of critically ill patients visiting the emergency room with chest pain or dyspnea, which is expected to improve patient prognosis." He added, "We will actively implement a step-by-step marketing strategy following non-reimbursement entry and fee confirmation by enhancing the completeness of the medical imaging platform optimized for the emergency room care environment."