Medical IP's X-ray image analysis software certified as medical device
Ji-Hyun Lee
Mar 08, 2023 (Gmt+09:00)
Medical IP, a South Korean medical AI company, has announced that its artificial intelligence (AI) medical image analysis software "TiSepX Lung Volumetry" has received Class 2 medical device certification from the Ministry of Food and Drug Safety.
The software calculates lung volume using chest X-rays and is the first TiSepX device to receive approval.
This is the first time that a TiSepX device, which uses AI to expand 2D X-rays into 3D images and then quantitatively analyzes organs, has been approved.
The lung volumetry device automatically analyzes lung volume data just by looking at X-rays, without the patient needing additional pulmonary function tests (PFT) or computed tomography (CT) scans. It is expected to be highly useful for diagnosing and monitoring interstitial lung disease and other similar conditions.
This certification is a significant milestone for Medical IP, which plans to expand its TiSepX lineup to include the analysis of the heart, bone and blood vessels.