Neurophet, an artificial intelligence (AI) company specializing in brain disease, announces that its Neurophet AQUA software has received U.S. FDA 510(K) clearance. Neurophet AQUA is a brain MRI analysis software designed to analyze brain atrophy observed in neurodegenerative diseases, including Alzheimer’s disease. This milestone allows Neurophet to enter the U.S. market, the largest medical device market globally.
Neurophet AQUA is capable of segmenting and analyzing brain images within 5 minutes, independent of factors such as race, age, or gender. This software enables healthcare professionals to diagnose and observe the progression of Alzheimer’s disease, which has recently garnered substantial attention due to the market growth of anti-amyloid antibody drugs.
Brain atrophy, a prominent feature observed in most Alzheimer’s patients, is also evident in individuals undergoing treatment with anti-amyloid antibody drugs, which target the removal of beta-amyloid proteins in the cerebral cortex. While the medical cause of drug-induced brain atrophy in Alzheimer’s patients remains unclear, continuous monitoring of brain atrophy during treatment is essential.
Neurophet intends to supply its products to the U.S. market through collaborations with companies providing radiology AI solution platform services. Currently, the company is engaged in discussions with relevant partners to facilitate the distribution of Neurophet AQUA.
Neurophet’s CEO, Jake Junkil Been, expressed enthusiasm about the FDA clearance, stating, “With FDA clearance, as well as CE marking and medical device approvals from Japan, Singapore, and Korea, Neurophet AQUA is primed for global market penetration through our proactive sales efforts.”
Been also highlights the significance of Neurophet SCALE PET, another product that received FDA clearance last August. This brain PET scan analysis software assists in determining the prescription for Alzheimer’s disease treatments, making it a tool for clinical trials and treatment decisions.
