French medical technology company Pixyl has received the US Food and Drug Administration (FDA) 510(k) approval for its next-generation AI software, Pixyl.Neuro, for brain MRI analysis.

Pixyl.Neuro is designed to automatically analyse brain MRI images to support rapid detection, early diagnosis and objective monitoring of neurological disorders.

It leverages generative AI technology to provide superior performance in real-world practice and has recently shown enhanced detection rates of up to 28%.

UC Davis neuroradiology division chief Lotfi Hacein-Bey said: “AI-driven MRI analysis opens the possibility of accessing previously unavailable clinically relevant information to reinforce radiology workflows, especially in the context of neurological disorders.

“With disease-modifying treatments for MS and now Alzheimer’s Disease, it is more important than ever to highlight activity and monitor disease evolution.”

The software is said to improve the detection of neurological disease activity, advance MRI reading time, and provide peace of mind for the 83% of MS MRI exams that are stable.

It quantifies the brain region volumes and compares them with normative data to identify abnormal atrophy earlier and help support differential diagnosis.

The AI-powered solution uses minimal MRI protocols and provides results within minutes.

Hacein-Bey added: “Pixyl’s FDA approval holds great promise for supporting the management of neurodegenerative and neuroinflammatory disorders.

“We chose Pixyl to answer our routine practice needs based on their track record of delivering high-quality brain MRI solutions. I am delighted to partner with Pixyl and I look forward to the benefits it will bring to our radiology workflow and patient care.”

Pixyl.Neuro has received the CE-mark class 2a certification in the European Union (EU), under the new Medical Device Regulations (MDR).

The solution has been used in more than 12 countries across Europe, North America and Africa, and its use increased by four-fold since December 2022, said the medical device maker.

Pixyl CEO Senan Doyle said: “It is incredibly rewarding to receive feedback from Pixyl.Neuro users who attest to this valuable support. We are delighted to work with US radiologists and imaging centres to reinforce radiology workflows and patient care.”

Last year, UK-based medical software developer Brainomix partnered with Pixyl to expand its offering with multiple sclerosis treatment solutions.