MEDICAL IP’s, X-ray based lung volumetry analysis S/W ‘TiSepX Lung Volumetry’ gains MFDS approval

“We have gained MFDS’s Class ll medical devices approval for ‘TiSepX Lung Volumetry’, our new medical image analysis software solution that calculates lung volume from chest X-ray.” said Sang Joon Pak, CEO of MEDICAL IP, a leading digital twin based medical AI solutions provider.

TiSepX Lung Volumetry was developed based on MEDICAL IP’s source technology used for development of the company’s earlier software, TiSepX*, a solution that 3 dimensionally analyzes 2 dimensional X-ray images.

*TiSepX : Tissue Separation from X-ray


TiSepX expands X-ray images into the 3 dimensional space to quantitatively analyze lungs and other organs. It used CT images for the development of its deep learning model for X-ray image analysis and lets one extract numerical information equivalent to the type of information extractable from CT images from 2 dimensional X-ray images.


TiSepX Lung Volumetry is a solution with specialized lung volumetry analysis function and automatically analyzes quantitative information from lung volume without the need of additional take of CT, PFT, or Plethysmography.


“TiSepX Lung Volumetry can be used for diagnosis and monitoring of interstitial lung disease,” said a representative from a company. “Our solution eliminates inefficiencies in time, cost and manpower needed for conventional lung volume tests making it an ideal solution for the elderly and critically ill patients with limited mobility.


Clinical relevance of TiSepX Lung Volumetry was addressed in an article published on Radiology last year titled, 「Deep Learning for Estimating Lung Capacity on Chest Radiographs Predicts Survival in Idiopathic Pulmonary Fibrosis」. Professor Ronald L. Sorkness of the University of Wisconsin-Madison said in the paper, "Fast, simple, and low-risk pulmonary measurement technology has the potential to replace conventional pulmonary testing."


TiSepX Lung Volumetry is the first case to complete the commercialization of TiSepX’s technology and the MFDS approval process. The company will expand its 3D analysis solution to other organs such as heart, bones, and vascular system.


 “Discussions with global X-ray device corporation for integration of TiSepX Lung Volumetry are already underway. We expect to complete international approval and certification process in the near future to continue to innovate the field of global X-ray analysis.” said Sang Joon Pak, CEO of MEDICAL IP.


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