Pixyl has announced FDA 510(k) clearance for Pixyl.Neuro™, the next-generation AI software for brain MRI analysis that recently demonstrated enhanced detection rates up to 28%1.
Pixyl is an award-winning French medtech 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.
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“AI-driven MRI analysis allows access to previously unavailable clinically-relevant information to reinforce radiology workflows, especially as comes to neurological disorders,” explains Pr. Lotfi Hacein-Bey, MD, Director, Division of Neuroradiology, UC Davis School of Medicine, Sacramento, CA. “The recent FDA approval of Pixyl’s software is a very positive step toward improved diagnosis, management and longitudinal follow up of neurodegenerative and neuroinflammatory disorders, especially with the advent of disease modifying treatments for MS, NMO and Alzheimer’s Disease.”
Pixyl.Neuro™ was designed to improve detection of neurological disease activity, accelerate MRI reading time, and provide peace-of-mind for the 83% of MS MRI exams 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 a matter of minutes.
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According to Pr. Hacein-Bey, “We believe Pixyl will be a game changer in neurological practice, especially in light of their track-record of delivering high-quality brain MRI solutions. I am delighted to partner with Pixyl and I look forward to significant benefits to our patients, scientific collaborations and our imaging workflow.”
Pixyl’s adherence to the latest FDA AI guidelines in obtaining approval underscores their commitment to developing high-quality medical imaging AI solutions. Additionally, Pixyl.Neuro has received the CE-mark class IIa certification in the European Union under the new Medical Device Regulations.
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Precision medicine heralds a new era in patient care. One where medical professionals using the latest AI solutions can rapidly access the information needed to diagnose and manage diseases earlier. As noted by Senan Doyle, CEO at Pixyl, “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 centers to reinforce radiology workflows and patient care”
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