Neurofit, 'Neurofit Aqua' obtained US FDA 510k... Laying the foundation for entering the world's largest medical device market

Friday, May 19, 2023

Both ‘Neurofit Aqua’ and ‘Neurofit Scale Pet’ obtained US FDA 510k certification - Plan to supply products to the US market by collaborating with a number of radiology AI solution platform companies

Neurofit, a company specializing in brain disease image artificial intelligence (AI) solutions, has obtained 510k Clearance (pre-market approval) from the U.S. Food and Drug Administration (FDA) for its neurodegeneration image analysis software, 'Neurophet AQUA' 18 the day said

Neurofit Aqua is a software medical device that analyzes brain atrophy observed in neurodegenerative diseases such as Alzheimer's disease by analyzing brain magnetic resonance imaging (MRI) with AI technology. Brain image segmentation and analysis are possible in just 5 minutes regardless of race, age, or gender.

In August of last year, Neurofit obtained 510k clearance from the FDA for its PET (positron emission tomography) image automatic analysis software, Neurophet SCALE PET. Along with Neurofit Scale Pet, the company obtained permission for Neurofit Aqua, its flagship product, and was able to enter the US, the world's largest medical device market, in earnest.

Neurofit plans to supply products to the US market by collaborating with a company that provides imaging medicine AI solution platform services. Currently, Neurofit is in the process of discussing the supply of Neurofit Aqua with a number of radiology AI solution platform companies.

Neurofit Aqua is expected to play an important role in the field of Alzheimer's disease diagnosis and treatment prescription prognosis monitoring, which is drawing attention as the anti-amyloid Alzheimer's disease treatment market has recently bloomed.

Abnormal brain atrophy is found in the brain MRI of the majority of Alzheimer's disease patients, and patients who are administered antibody treatments that remove beta amyloid protein accumulated in the brain cortex often experience brain atrophy. Although the cause of brain atrophy caused by the administration of Alzheimer's disease drugs has not been clarified medically, it is important to continuously observe brain atrophy during the administration period, so demand for Neurofit Aqua, which analyzes brain atrophy, is expected to increase.

Bin Joon-gil, CEO of Neurofit, said, “Neurofit Aqua is a product that has obtained medical device approval in a total of five countries including Europe, Japan, and Singapore as well as the US FDA 510k. “As the brain image analysis technology of Neurofit Aqua and the technology of Neurofit Scale Pet, which quantitatively analyzes PET images, which determine the prescription of Alzheimer’s disease treatment, have been recognized by the US FDA, they are essential in the field of clinical and prescription treatment for Alzheimer’s disease. We expect to be able to use it.”

“We responded to the future expansion of the dementia treatment market by presenting vascular neuropathology quantification technology that can be used for the analysis of ‘ARIA (Amyloid-Related Imaging Abnormalities),’ a side effect of anti-amyloid treatment, at the European Society of Radiology held in March. We are positioning ourselves to do so,” he said.



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