AI Software Platform Receives CE Mark Approval

A broad machine vision and deep-learning software platform, which supports the assessment of multiple clinical indications, including the detection of intracranial hemorrhage (ICH), has received the CE Mark approval. The software platform named Accipio has been developed by MaxQ Artificial Intelligence (Andover, MA, USA), a global artificial intelligence (AI) healthcare company focusing on empowering confident, life-saving decision support through AI-enabled tools at the point of care.

Accurate and timely detection of ICH, commonly known as a brain bleed, is a critical step in clinical decision-making for stroke assessment and head trauma. AccipioIx, the first of multiple Accipio versions, is based on deep-learning technologies, which automatically analyzes non-contrast head computed tomography (CT) images. The AI AccipioIx algorithm is highly sensitive to the presence of ICH, identifying and prioritizing patients with ICH for the physician treating the patient. It provides a case-level signal, allowing rapid triage and prioritization of the patient and can be natively integrated into PACS systems, medical imaging hardware, or healthcare clouds. AccipioIx is now approved for commercial sale within the European Union.

"We are delighted to receive the CE Mark for AccipioIx, the first of many global regulatory approvals," said Gene Saragnese, Chairman and CEO of MaxQ-AI. "At MaxQ-AI we are developing a suite of advanced clinical decision support and workflow tools for acute healthcare physicians and their patients on a global basis. Designed to provide actionable insights, our platform leverages the power of AI, combined with the skill of the physician, leading to better patient outcomes and improved healthcare economics."

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