South Korea-based Medical IP has received the US Food and Drug Administration (FDA) 510(k) approval for its AI-powered automatic body composition analysis software, DeepCatch.
DeepCatch is a software as a medical device (SaMD) that automatically segments and analyses anatomical structures and body composition using computed tomography (CT) scans.
The AI software analyses multiple body parts, such as skin, bone, muscle, visceral fat, subcutaneous fat, internal organ, and central nervous system.
It provides the analysis results in the form of a report that contains 3D visual and quantitative information.
DeepCatch is the only FDA-approved AI software that automatically analyses several body components, said the medical technology company.
Medical IP CEO Joon S Park said: “There are various diseases related to body composition, such as geriatric diseases, cardiovascular diseases, and metabolic diseases such as diabetes and sarcopenia in the elderly and cancer patients, and DeepCatch is a product that can provide additional clinical information on these diseases.
“DeepCatch can be introduced to any medical institution around the world that takes CT scans, so with this FDA Clearance, we will be able to accelerate our strategy for global expansion.”
According to the company, DeepCatch has the capability to provide accurate body composition analysis results to anyone regardless of race, gender, or age.
The AI software was tested for bias of various CT scanners, medical institutions, race, and ethnicity in a series of multi-national clinical trials, including in the US.
Its safety and performance were validated based on the accuracy of AI-based analysis, including the measurement of the volume and area of body components and the body circumference.
Unlike BIA and DXA methods, DeepCatch can actively derive clinically valid 3D body composition analysis results and presents a new standard for body composition, said the company.
BIA (Bioelectrical Impedance Analysis) methods are affected by the measurement environment or body condition and DXA (Dual-Energy X-ray Absorptiometry) methods cannot separately quantify areas such as visceral fat in 3D.
The FDA approval will enable the rapid commercialisation of DeepCatch in the US.
Medical staff can perform additional screening for possible body composition-related diseases based on the DeepCatch report.
Also, patients can obtain additional medical information about diseases such as obesity, metabolic diseases and sarcopenia using CT images.
