Pixyl receives FDA clearance for AI-powered brain MRI software

Pixyl, a leading French medtech specialising in AI-powered MRI solutions, has secured FDA 510(k) clearance for its Pixyl.Neuro™ software, a next-gen tool for brain MRI analysis. With enhanced detection rates of up to 28%, the software supports rapid detection, early diagnosis, and objective monitoring of neurological disorders using generative AI technology.

Pixyl.Neuro™ accelerates MRI reading time, particularly for stable cases, quantifying brain region volumes and identifying abnormal atrophy earlier in the diagnostic process. It received CE-mark class IIa certification in the EU and adheres to the latest FDA AI guidelines, showcasing Pixyl's commitment to high-quality medical imaging AI solutions.

Professor Lotfi Hacein-Bey from UC Davis highlights the software's promise in managing neurodegenerative and neuroinflammatory disorders. Pixyl.Neuro™ has gained popularity in over 12 countries, witnessing a four-fold increase in exam volume since December 2022. Available directly from Pixyl and select distributors, the software receives positive feedback for its valuable support in radiology workflows and patient care.

Pixyl, founded to advance AI in medical imaging, participates in collaborative projects like the PRIMUS (Projection In Multiple Sclerosis) project and the AI.Dream consortium for hepatic applications.