Pixyl.Neuro™, Pixyl's innovative AI-driven brain MRI software, has received FDA clearance
Tuesday, November 21, 2023
Pixyl has recently received FDA 510(k) clearance for Pixyl.Neuro™, an advanced AI software designed for brain MRI analysis. The software has demonstrated a notable improvement in detection rates, showing an increase of up to 28%1.
Pixyl is a renowned French medtech company specializing in AI-driven MRI solutions to enhance patient care. Pixyl.Neuro™ autonomously examines brain MRI images, facilitating rapid detection, early diagnosis, and objective monitoring of neurological disorders. It utilizes generative AI technology to ensure robust performance in real-world scenarios. Pixyl.Neuro™ aims to enhance the identification of neurological disease activity, expedite MRI reading time, and offer reassurance for the 83% of stable MS MRI exams2.
The software quantifies brain region volumes and compares them to normative data, enabling the early identification of abnormal atrophy to support a more informed differential diagnosis. The solution operates with minimal MRI protocols and delivers results within minutes. Pixyl's commitment to adhering to the latest FDA AI guidelines underscores its dedication to developing high-quality medical imaging AI solutions. Additionally, Pixyl.Neuro has obtained CE-mark class IIa certification in the European Union under the new Medical Device Regulations.