Pixyl.Neuro, a generative AI software for brain MRI analysis has received FDA approval. The US is now one of 12 countries where the platform has been approved by regulators.
French medtech company Pixyl has announced FDA 510(k) clearance for its Pixyl.Neuro software, a next-generation AI software for brain MRI analysis. the platform recently demonstrated enhanced detection rates of up to 28 per cent.
Pixyl.Neuro automatically analyses brain MRI images to support rapid detection, early diagnosis and objective monitoring of neurological disorders using generative AI.
“AI-driven MRI analysis opens the possibility of accessing previously unavailable clinically relevant information to reinforce radiology workflows, especially in the context of neurological disorders,” said Professor Lotfi Hacein-Bey, chief of division 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 evolution.”
Pixyl.Neuro was designed to improve the detection of neurological disease activity, accelerate MRI reading time and provide peace of mind for the 83 per cent of MS MRI exams that are stable.
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.
Professor Hacein-Bey added: “Pixyl’s FDA approval holds great promise for supporting the management of neurodegenerative and neuroinflammatory disorders. We chose Pixyl to answer our routine practice needs based on their track record of delivering high-quality brain MRI solutions. I am delighted to partner with Pixyl and I look forward to the benefits it will bring to our radiology workflow and patient care.”
Pixyl.Neuro has also received the CE-mark class IIa certification in the European Union under the new Medical Device Regulations.
Senan Doyle, CEO at Pixyl said: “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 centres to reinforce radiology workflows and patient care”
Pixyl.Neuro is used in more than 12 countries across Europe, North America and Africa, and has observed a four-fold increase in exam volume since December 2022.
