Neurofit Obtains US FDA Approval for PET Imaging Auto-Analysis Software 'Neurofit Scale PET'

[Asia Economy Reporter Jang Hyowon] Neurophyt, a specialized company in AI solutions for brain disease imaging, announced on the 16th that it has received formal approval (510k Clearance) from the U.S. Food and Drug Administration (FDA) for its PET image automatic analysis software, ‘Neurophet SCALE PET’.

Neurophet SCALE PET is a PET (Positron Emission Tomography) image automatic analysis software that quantitatively analyzes Alzheimer’s disease biomarkers by combining PET images and MRI (Magnetic Resonance Imaging). Utilizing Neurophyt’s proprietary AI technology, it automatically provides SUVR (Standardized Uptake Value Ratio) for amyloid beta protein, one of the Alzheimer’s disease biomarkers, and decreased brain neuron metabolism.

When diagnosing Alzheimer’s disease using PET images, two main methods are used: confirming amyloid beta protein deposition in brain tissue through amyloid-PET images, and checking for decreased metabolism of brain neurons through FDG (Fluorodeoxyglucose)-PET images. Since doctors or brain imaging specialists visually inspect PET images directly for diagnosis, there are cases where disease determination is difficult. Existing analysis software requires cumbersome manual work, taking about 10 hours or more just for image analysis.

Neurophet SCALE PET uses its core technology, ‘Neurophet SegEngine,’ to quantify amyloid beta protein deposition in detailed brain regions within 15 minutes. As Alzheimer’s disease progresses, glucose metabolism in brain neurons decreases, and Neurophet SCALE PET also provides numerical values for the degree of glucose metabolism reduction observed in FDG-PET images. Among PET image software developed recently in Korea, Neurophet SCALE PET is the first to receive FDA certification for software that quantitatively shows the degree of glucose metabolism.

Neurophyt is advancing product enhancement for Neurophet SCALE PET and the brain neurodegeneration image analysis software ‘Neurophet AQUA,’ and is promoting the ‘ATNV Project,’ which aims to establish global standards for dementia and Alzheimer’s disease diagnosis. The ATNV Project quantifies Alzheimer’s disease biomarkers ‘Amyloid (A) - Tau (T) - Neurodegeneration (N) - Vascular neuropathology (V)’ using AI image analysis technology to identify types and stages of dementia.

Bin Jungil, CEO of Neurophyt, said, “With FDA approval of Neurophet SCALE PET, we can now actively enter the U.S. market, the world’s largest medical device market,” and added, “The practical review for FDA approval of Neurophet AQUA is also underway, and we expect to receive approval as early as this year.”

He continued, “Neurophet SCALE PET can greatly assist in the early diagnosis of Alzheimer’s disease and can also be effectively used in clinical research during the development of dementia drugs utilizing Alzheimer’s disease biomarkers, so demand for the product is expected to continuously increase in the future.”