'Neurofit Aqua AD Plus' Receives FDA 510(k) Clearance

Alzheimer's Imaging Analysis Solution
"Neurofit Product Receives Third FDA Clearance"

Neurofit, an artificial intelligence (AI) company specializing in the diagnosis and treatment of brain diseases, announced on February 3 that its brain imaging analysis solution, "Neurofit Aqua AD Plus," which supports the prescription of Alzheimer's disease treatments, has received 510(k) premarket notification clearance from the U.S. Food and Drug Administration (FDA).

Neurofit Aqua AD Plus promotional image. Neurofit

With this approval, Neurofit has secured its third FDA clearance, following its neurodegeneration imaging analysis software "Neurofit Aqua" and its positron emission tomography (PET) image quantification software "Neurofit Scale PET."

Neurofit Aqua AD Plus is an integrated solution that provides the brain imaging analysis functions required for prescribing Alzheimer's disease treatments. By quantitatively analyzing magnetic resonance imaging (MRI) and PET images, it supports clinical decision-making throughout the treatment cycle—from determining eligibility for prescription before drug administration, to monitoring side effects during administration, and evaluating treatment efficacy after administration.

The newly FDA-approved product is an advanced version of the existing "Neurofit Aqua AD." Through AI-based brain MRI analysis, it automatically analyzes the location and number of low-intensity lesions associated with cerebral microbleeds and superficial siderosis, as well as high-intensity lesions related to brain edema. This enables a more precise assessment of risk factors associated with anti-amyloid antibody therapies.

Bin Joongil, Co-CEO of Neurofit, stated, "With this FDA approval, we can now actively introduce Neurofit's imaging analysis technology to the U.S. market for Alzheimer's disease treatment," adding, "We plan to strengthen our global business by expanding collaborations with medical institutions in North America."

This content was produced with the assistance of AI translation services.