510(k) clearance for artificial intelligence software developed to enhance an acute care physician’s ability to identify and prioritize brain bleed stroke or head trauma
MaxQ AI, a clinical diagnostics intelligence platform company, announced that its revolutionary Accipio Ix intracranial hemorrhage (ICH) detection software has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The clearance paves the way for healthcare providers and physicians in acute care settings to have access to this artificial intelligence (AI) software designed to aid in prioritizing the clinical assessment of adult non-contrast head computed tomography (CT) cases that exhibit indications of intracranial hemorrhage (ICH), commonly known as a brain bleed.
“We are very pleased to receive FDA 510(k) clearance for Accipio Ix, which we believe will be a transformative solution for medicine,” said Gene Saragnese, Chairman and CEO of MaxQ AI. “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.”
Earlier this year, MaxQ announced CE Mark approval and commercial availability in the European Union. Now, Accipio Ix, is cleared for commercial sale within the United States. Accipio Ix leverages artificial intelligence 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). The AI-powered Accipio Ix, part of MaxQ’s unique Accipio INSIGHT™ platform, is designed to be highly sensitive to the presence of ICH, identifying and prioritizing patients with ICH for the treating physician. It provides a 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.
“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,” added Saragnese. “The potential impact is massive – only one patient diverted from acute stroke to wellness in the 13,000 U.S./E.U. hospitals represent $2 billion savings in a single year, and a lifetime of difference to the patient and their families.”