FDA Clears AI-Powered MRI Software to Assess for Brain Atrophy

The Food and Drug Administration (FDA) has granted 510(k) clearance for Neurophet AQUA (Neurophet), an artificial intelligence (AI) software that may enhance the assessment of brain atrophy on magnetic resonance imaging (MRI).¹

Neurophet said the Neurophet AQUA software takes five minutes to perform segmentation and analysis of MRI images.

The company noted the software can not only facilitate the diagnosis of brain atrophy in patients with neurodegenerative diseases such as Alzheimer’s disease, it can also be utilized for treatment monitoring for patients receiving anti-amyloid beta medications. A recently published meta-analysis found that anti-amyloid beta treatment may accelerate the development of brain atrophy in patients with Alzheimer’s disease.2

Neurophet previously received FDA 510(k) clearance for the Neurophet SCALE PET, a brain positron emission tomography (PET) analysis software, in August 2022.

The company, based in Seoul, South Korea, added that it is currently looking into avenues of distribution for both modalities in the United States.

References

1. Neurophet. Neurophet receives FDA 510(k) clearance for Neurophet AQUA. Cision PR Newswire. Available at: https://www.prnewswire.com/news-releases/neurophet-receives-fda-510k-clearance-for-neurophet-aqua-301828253.html . Published May 18, 2023. Accessed May 18, 2023.

2. Alves F, Kalinowski P, Ayton S. Accelerated brain volume loss caused by anti-B-amyloid drugs: a systematic review and meta-analysis. Neurology. 2023;100(20):e2114-e2124. Doi: 10.1212/WNL.0000000000207156. Epub 2023 Mar 27.

(Editor’s note: For related content, see “TeraRecon Launces AI-Powered Neuro Suite,” “Emerging Prostate and Brain MRI AI Platform Gets FDA Nod” and “Portable MRI System Gets FDA Nod for AI-Powered Brain Imaging Software.”)