Avicenna.AI gets 510(k) clearance for CINA-CSpine tool

The U.S. Food and Drug Administration (FDA) has approved Avicenna.AI’s CINA-CSpine tool under the 510(k) clearance. This AI-driven solution is designed to automatically identify and prioritize critical conditions, evaluate their severity, and promptly notify clinicians. Specifically, CINA-CSpine aids in detecting and triaging cervical spine fractures from computed tomography (CT) scans. These fractures, which often result from trauma, can lead to significant neurological damage or paralysis if not addressed quickly. By expediting the detection process, the tool aims to improve patient outcomes and minimize long-term complications.

The AI system flags potential acute cervical spine fractures, alerting radiologists through their existing workflows. According to Avicenna.AI co-founder and CEO Cyril Di Grandi, accurate diagnosis is vital, especially when spinal cord involvement is suspected. The tool was validated using over 300 non-contrast CT scans from the U.S. and Europe, showcasing sensitivity and specificity rates of 90.3% and 91.9%, respectively.