July 14, 2020
Avicenna.AI’s Cina Head Neurovascular Imaging Tool Cleared by FDA
July 14, 2020—Avicenna.AI, a France-based company focused on medical imaging artificial intelligence (AI), announced it has received FDA 510(k) clearance for its Cina Head triage AI solution for neurovascular emergencies.
The FDA clearance covers Cina’s automatic detection capabilities for both intracranial hemorrhage (ICH) and large vessel occlusion (LVO) from CT-scan imaging.
According to the company, Cina Head uses a combination of deep learning and machine learning technologies to automatically detect and prioritize acute ICH and LVO cases within 20 seconds, to alert radiologists within their existing systems and workflow.
Cina’s ICH detection capability was validated using data from 814 cases conducted at > 250 imaging centers across the United States demonstrating 96% accuracy, 91.4% sensitivity, and 97.5% specificity. The product’s LVO detection capability was validated based on 476 cases with 97.7% accuracy, 97.9% sensitivity, and 97.6% specificity.
Radiologist Peter Chang, MD, a cofounder of Avicenna.AI, commented in the company’s announcement, “When dealing with a stroke, time is of the essence and being able to prioritize effectively is critical to saving lives and improving outcomes. Not only does Cina Head help radiologists to identify pathologies quickly, but also to highlight those that require the most urgent care.”
Cina Head is Avicenna.AI’s first product for emergency radiology. Subsequent products in the trauma and vascular fields are expected to be unveiled in the next 12 months, advised the company.