French Firm Pixyl’s AI Brain MRI Analysis Software Gets FDA Greenlight

Pixyl has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for Pixyl.Neuro, its artificial intelligence (AI) software for analyzing MRIs of the brain.
 
Pixyl.Neuro, according to the company, automatically analyzes brain MRI images in order to support rapid detection, early diagnosis, and objective monitoring of neurological disorders. Its generative AI capabilities aim to boost real-world practice performance.
 
Brain region volumes are quantified, then compared to normative data to spot abnormal brain atrophy and facilitate differential diagnosis. Pixyl said the tool uses minimal MRI protocols and generates results in minutes.
 
According to research data¹, the software demonstrated enhanced detection rates up to 28%.
 
“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.” explained Pr. 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 also gained CE mark class IIa certification in the EU under the new Medical Device Regulations (MDR). The company said it’s used in 12 countries across Europe, North America, and Africa, and has reached a four-fold increase in exam volume since December 2022.
 
“Pixyl’s FDA approval holds great promise for supporting the management of neurodegenerative and neuroinflammatory disorders,” said Pr. Hacein-Bey.
 
“It is incredibly rewarding to receive feedback from Pixyl.Neuro users who attest to this valuable support,” said Pixyl CEO Senan Doyle. “We are delighted to work with U.S. radiologists and imaging centers to reinforce radiology workflows and patient care.”
 
Reference
¹ Dehaene et al. Radiologists and Artificial Intelligence on clinically relevant metrics for detecting activity in Multiple-Sclerosis patients. ESNR 2023