Neurophet, an artificial intelligence (AI) company specializing in the diagnosis and treatment of brain diseases, said on the 3rd that its comprehensive brain imaging analysis solution, Neurophet AQUA AD Plus, received 510(k) clearance—pre-market notification approval—from the U.S. Food and Drug Administration (FDA).
The FDA's 510(k) clearance is a system that allows sales in the U.S. market if a product is judged to be substantially equivalent to a medical device already on the market.
Previously, Neurophet also obtained the same approval for its neurodegeneration imaging analysis software Neurophet AQUA and PET imaging quantitative analysis software Neurophet SCALE PET.
Neurophet AQUA AD Plus quantitatively analyzes brain imaging such as MRI (magnetic resonance imaging) and PET (positron emission tomography) required in the prescription process for Alzheimer's disease treatments. Based on this, it supports clinical decision-making across the entire treatment cycle, from determining a patient's eligibility before administering the therapy, to monitoring side effects during administration, to analyzing treatment effects after administration. This was selected as an innovative medical technology in Korea in Sep. last year.
Neurophet AQUA AD Plus, which the company plans to supply in the U.S., is an upgraded version that advances the functions of the existing Neurophet AQUA AD. Through AI-based brain MRI analysis, it can automatically analyze the location and number of low-intensity lesions associated with cerebral microbleeds and superficial siderosis, and high-intensity lesions related to brain edema. Superficial siderosis is a neurological disease in which repeated microbleeds on the brain surface cause iron to accumulate, leading to hearing loss, gait disturbance, and other symptoms.
With this, clinicians can more precisely assess risk factors related to anti-amyloid antibody therapies and develop personalized treatment plans for each patient.
Bin Jun-gil, co-CEO of Neurophet, said, "With this FDA pre-market notification approval for Neurophet AQUA AD Plus, we can fully showcase Neurophet's technological competitiveness in the Alzheimer's treatment field in the U.S. market," adding, "We plan to accelerate global business expansion by broadening partnerships with medical institutions in the Americas."