FDA Clears AI-Powered Brain MRI Software Pixyl.Neuro

Pixyl.Neuro™, the cutting-edge AI brain MRI software from award-winning French medtech Pixyl, has received FDA 510(k) clearance, showcasing a remarkable 28% improvement in detection rates. This AI solution enhances neurological disorder diagnosis, monitoring, and early detection, utilizing generative AI technology for robust real-world performance.

Renowned medical professionals, like Pr. Lotfi Hacein-Bey from UC Davis School of Medicine, hail Pixyl’s software approval as a positive stride in managing neurodegenerative disorders. Pixyl.Neuro™ promises to revolutionize neurological practice by swiftly analyzing MRI images, reducing reading time, and offering crucial insights for disorders like MS.

Designed for precision, Pixyl.Neuro™ identifies abnormal brain atrophy earlier through minimal MRI protocols, delivering results within minutes. Its impact is already evident in over 12 countries, witnessing a four-fold increase in exam volume since December 2022.

Pixyl’s commitment to FDA guidelines and CE-mark class IIa certification reflects their dedication to high-quality medical imaging AI solutions. Senan Doyle, Pixyl’s CEO, expresses delight in working with radiologists globally to enhance workflows and patient care.

Pixyl’s success extends beyond neurology, with ongoing collaborations in hepatic applications through the AI.Dream consortium. Their vision is to empower medical professionals with advanced AI solutions for accurate and early disease management.

Author: Neurologica