The U.S. Food & Drug Administration (FDA) has given 510(k) clearance to Pixyl.Neuro, brain MRI analysis software that’s powered by artificial intelligence (AI).

In a Nov. 20 news announcement, Pixyl, a French medtech company specializing in AI-powered MRI solutions to improve patient care, said Pixyl.Neuro “automatically analyzes brain MRI images to support rapid detection, early diagnosis and objective monitoring of neurological disorders, leveraging generative AI technology to ensure robust performance in real-world practice.”

The announcement included comments from Lotfi Hacein-Bey, M.D., Director of the division of neuroradiology at the UC Davis School of Medicine in Sacramento, Calif.

“AI-driven MRI analysis allows access to previously unavailable clinically relevant information to reinforce radiology workflows, especially as comes to neurological disorders,” Hacein-Bey said. “The recent FDA approval of Pixyl’s software is a very positive step toward improved diagnosis, management and longitudinal follow-up of neurodegenerative and neuroinflammatory disorders, especially with the advent of disease-modifying treatments for MS [multiple sclerosis], NMO [neuromyelitis optica] and Alzheimer’s disease.”

He added that he believes the Pixyl software “will be a game changer in neurological practice, especially in light of their track record of delivering high-quality brain MRI solutions.”

Pixyl said its AI-powered system “accurately predicted the future clinical disability of multiple sclerosis patients from a single MRI sequence.”

Noting that physicians commonly use MRI to diagnose and examine MS activity, Pixyl said its software “automatically analyzes MRI images in just four to five minutes, providing access to quantified measures of lesion volume and brain atrophy.”

Pixyl also has software to diagnose and provide imaging surveillance for traumatic brain injuries and stroke.

Image: istockphoto/burcu saritas