"AI Tool Gains Approval for Detecting Cervical Spine Fractures"

 

Avicenna.AI Secures FDA Clearance for CINA-CSpine Algorithm for Cervical Spine Fracture Detection

Sept. 19, 2024 – Avicenna.AI, a leader in medical imaging AI, has obtained 510(k) clearance from the U.S. Food and Drug Administration for its CINA-CSpine algorithm, a tool designed to assist in the detection and triage of cervical spine fractures using CT imaging.

CINA-CSpine is engineered to identify and flag potential acute cervical spine fractures, automatically alerting radiologists through existing medical systems. Early detection is crucial, as timely treatment can significantly impact recovery outcomes and reduce the risk of long-term complications.

"Cervical spine fractures are critical injuries that demand swift and accurate diagnosis, particularly when the spinal cord is at risk," said Cyril Di Grandi, co-founder and CEO of Avicenna.AI. "With CINA-CSpine, we aim to reduce the time between scan and interpretation, ensuring that patients receive the care they need as quickly as possible."

The algorithm was validated using over 300 non-contrast CT scans from multiple sources across the U.S. and Europe, covering 36 scanner models from five different vendors. CINA-CSpine demonstrated an impressive sensitivity of 90.3% and a specificity of 91.9%, compared to the expert consensus of three U.S. board-certified radiologists.

“These results underscore the algorithm's capability to provide rapid, accurate findings, helping physicians make better assessments and improve patient care,” added Di Grandi.