Pixyl has achieved 510(k) clearance from the US Food and Drug Administration (FDA) for its next-generation artificial intelligence (AI)-powered brain MRI analysis software, Pixyl.Neuro.
The new software is intended to automatically analyze brain MRI images to quickly identify, diagnose and monitor neurological disorders.
The company has developed the software to improve the detection of neurological disease activity, speed up MRI reading times and provide peace of mind for 83% of stable MS MRIs.
Pixyl.Neuro helps quantify and compare brain region volumes with normative data for early abnormal atrophy detection and enables differential diagnosis.
It uses minimal MRI protocols and delivers results within minutes.
Pixyl CEO Senan Doyle said: “It is incredibly rewarding to receive feedback from Pixyl.Neuro users who attest to this valuable support.
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“We are excited to work with American radiologists and imaging centers to strengthen radiology workflows and patient care.”
The company has already received CE mark IIa certification for the Pixyl.Neuro software in the EU under the new medical device regulations.
Moreover, this software is used in over 12 countries spanning North America, Europe and Africa.
UC Davis Neuroradiology Division Chief Lotfi Hacein-Bey said, “Pixyl’s FDA approval holds great promise for supporting the management of neurodegenerative and neuroinflammatory disorders.
“We chose Pixyl to meet our routine practice needs based on their track record of providing high-quality brain MRI solutions.”