Pixyl receives FDA approval for AI-powered brain MRI software Pixyl.Neuro™

GRENOBLE, France, 20 November 2023 /PRNewswire/ — Pixyl has announced FDA 510(k) clearance for Pixyl.Neuro™, next-generation AI software for brain MRI analysis that recently demonstrated improved detection rates up to 28%1.

Pixyl is a award winning French medical technology specializing in AI-powered MRI solutions to improve patient care. 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.

“AI-powered MRI analysis opens up the possibility of accessing previously unavailable clinically relevant information to enhance radiology workflows, particularly in the context of neurological disorders.” explains Pr. Lotfi Hacein-Bey, division chief of neuroradiology at UC Davis. “With disease-modifying treatments for MS and now Alzheimer’s disease, it is more important than ever to highlight activity and monitor disease progression.”

Pixyl.Neuro™ is designed to improve detection of neurological disease activity, speed up MRI reading times and provide peace of mind to the 83% of MS MRIs that are stable2. Brain region volumes are quantified and compared to normative data to identify abnormal atrophy earlier and help support differential diagnosis. The solution uses minimal MRI protocols and provides results in minutes.

According to Prof. Hacein-Bey, “Pixyl’s FDA approval holds great promise to support the management of neurodegenerative and neuroinflammatory disorders. We chose Pixyl to meet our routine needs based on their track record of providing high-quality brain MRI solutions. I am pleased to partner with Pixyl and I look forward to the benefits it will bring to our radiology workflow and patient care.”

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Pixyl’s compliance with the latest FDA AI guidelines to achieve approval underscores their commitment to developing high-quality medical imaging AI solutions. In addition, Pixyl.Neuro has received CE mark class IIa certification in the European Union according to the new Medical Device Regulations.

Precision medicine ushers in a new era of patient care. One where doctors using the latest AI solutions can quickly access the information needed to diagnose and manage diseases earlier. As noted by Late DoyleCEO at Pixyl, “It is incredibly rewarding to receive feedback from Pixyl.Neuro users attesting to this valuable support. We are excited to work with US radiologists and imaging centers to strengthen radiology workflows and patient care.”

Pixyl.Neuro is used in more than 12 countries across the board Europe, North America and Africaand has observed a fourfold increase in exam volume since December 2022.

The solution is available directly from Pixyl and from selected retailers.

About Pixyl
Pixyl was founded to put the most advanced AI for medical imaging directly into the hands of radiologists and clinicians. Starting from brain MRI applications, the company rose to prominence by winning the data challenge from the French Radiology Society, where Pixyl’s AI technology accurately predicted the future clinical impairment of multiple sclerosis patients from a single MRI sequence. In collaboration with the French Observatory of Multiple Sclerosis (OFSEP), Pixyl is driving innovation in the next generation of predictive imaging solutions. PIXYL is also a partner in the PRIMUS project (Projection In Multiple Sclerosis), which was awarded the prestigious University Hospital Health Research (RHU) funding in 2021.

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Expanding their portfolio of MRI applications, and since launching in 2020, PIXYL has been a partner in the AI.Dream consortium, led by GE HealthCare (GEHC) and Pr. Valérie Vilgrain (Chief of Radiology, Beaujon Hospital, APHP), aiming to promote joint development of next-generation AI hepatic applications.

For more information, please visit www.pixyl.ai or contact us by e-mail at [email protected]

Press kit link: https://rsna.vporoom.com/Pixyl

1 Dehaene et al. Radiologists and artificial intelligence on clinically relevant measurements for detecting activity in multiple sclerosis patients. ESNR 2023

2 Cohan, S. & al. (2016). BMC Neurology 16 doi:10.1186/s12883-016-0699-8