Medical IP's DeepCatch Software Granted FDA 510(k) Clearance for Whole-Body Composition CT Quantification
Medical IP, under the leadership of CEO Joon S. Park, has announced that their AI software called DeepCatch has received US FDA 510(k) Clearance. DeepCatch is an automatic body composition analysis AI software that utilizes CT scans to provide comprehensive reports with 3D visualizations and quantitative information. It is the only FDA-cleared AI software capable of automatically analyzing various body components, including skin, bone, muscle, visceral fat, subcutaneous fat, internal organs, and the central nervous system through whole-body CT scans.
The FDA clearance for DeepCatch is significant as it allows for the software to be quickly introduced into the medical field in the United States. It provides healthcare professionals with the opportunity to conduct additional screenings for body composition-related diseases based on the DeepCatch reports. Additionally, patients can benefit from obtaining additional medical information about conditions such as obesity, metabolic diseases, and sarcopenia by utilizing CT images acquired during hospital treatments or health checkups. This enables individuals to manage their health more efficiently and proactively.
DeepCatch has undergone extensive testing during the FDA clearance process, including validation of its accuracy and performance on various CT scanners, medical institutions, races, and ethnicities through multinational clinical trials, including those conducted in the United States. The software has demonstrated accurate body composition analysis results, including measurements of volume, area, and body circumference. With its ability to derive clinically valid 3D body composition analysis results using CT scans, DeepCatch is expected to set a new standard in the field.
The FDA clearance opens up opportunities for DeepCatch to be implemented in medical institutions worldwide that utilize CT scans. Its applications are diverse, as various diseases are related to body composition, including geriatric diseases, cardiovascular diseases, metabolic diseases such as diabetes and sarcopenia in the elderly, and conditions affecting cancer patients. DeepCatch provides valuable clinical information on these diseases and contributes to the advancement of the medical industry through its fast, accurate, and efficient CT-based body composition analysis technology.