FDA Clears NeuroQuant PET for Assessment of Neurological Conditions

The Food and Drug Administration (FDA) has granted 510(k) clearance for NeuroQuant PET, an AI-enabled software that provides automated assessment for Alzheimer’s disease and other neurocognitive disorders.

NeuroQuant PET offers atlas-based quantification and regional segmentation analysis for amyloid PET imaging, according to Cortechs.ai, the developer of NeuroQuant PET. The company added that the software generates automated centiloid quantification with the use of multiple amyloid PET agents including flutemetamol (Vizamyl, GE HealthCare), florbetaben (Neuraceq, Life Molecular Imaging/Lantheus) and florbetapir (Amyvid, Eli Lilly).

Facilitating integration of the software’s quantitative analysis into existing systems, Coretechs.ai said NeuroQuant PET offers compatibility with PET/CT, PET/MRI and PET-only workflows.

“Automated quantitative PET imaging represents the next frontier in precision and personalized medicine for Alzheimer's disease and related neurocognitive disorders. These new technological advancements are enabling the shift from phenotype-based assessment to a biological, biomarker-driven approach in assessing neurodegenerative disease. I am excited about the role NeuroQuant PET will play in shaping the future of how these conditions are understood and managed,” said Ana Franceschi, MD, PhD, the director of dementia imaging and molecular neuroimaging at Northwell Health in New York City.