New AI Software for Brain Bleed Diagnosis Receives FDA Clearance

The US Food and Drug Administration (FDA) has given 510(k) clearance to the Accipio Ix intracranial hemorrhage (ICH) detection software developed by MaxQ AI (Tel Aviv, Israel), a clinical diagnostics intelligence platform company.

This will provide healthcare providers and physicians in acute care settings with access to the artificial intelligence (AI) software which has been designed to aid in prioritizing the clinical assessment of adult non-contrast head computed tomography (CT) cases that exhibit indications of ICH, commonly known as a brain bleed.


MaxQ AI develops clinical diagnostic intelligent software solutions that enable timely and more accurate diagnosis as well as allow physicians to provide 'smarter care' with AI clinical insights. The company’s Accipio Ix ICH detection software leverages AI technology to automatically analyze non-contrast head CT images without workflow impact to the reader, altering the original series or storing Protected Health Information (PHI). Accipio Ix, part of MaxQ's Accipio INSIGHT platform, is designed to be highly sensitive to the presence of ICH, identifying and prioritizing patients with ICH for the treating physician. The AI-powered software provides the capability for rapid escalation and prioritization of the patient and can be natively integrated into CT and PACS systems using the imaging industry-standard DICOM, installed both on-premise and cloud-capable.

"MaxQ's Accipio application, of which Accipio Ix is the first part of the ecosystem, provides physicians with actionable intelligence, improving their future ability to make a timely, accurate and more confident diagnosis of a brain bleed," said Gene Saragnese, Chairman and CEO of MaxQ AI. "Accipio Ix's ability to greatly increase suspected bleed detection, improve escalation and time to review is a game-changer. Further, our partnerships with top CT and PACS companies, including GE Healthcare, Samsung Neurologica and other organizations prior announced, make deployment and adoption of Accipio straightforward."

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