Avicenna.AI Wins FDA Nod for AI Tool to Spot Cervical Spine Fracture

Avicenna.AI has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its CINA-CSpine tool.
 
CINA-CSpine is an artificial intelligence (AI) tool to support detection and triage of cervical spine fractures from CT images. These fractures, a break in one or more of the seven vertebrae in the neck, are typically caused by traumatic injury and can lead to spinal cord injury.
 
Prompt detection and appropriate treatment are crucial to optimize outcomes and minimize long-term complications from cervical spine fractures. CINA-CSpine automatically flags suspected positive findings compatible with acute cervical spine fractures, alerting radiologists through their existing systems.
 
The technology was validated on over 300 non-contrast CT scans from multiple U.S. and European sources, acquired from 36 different scanner models from five vendors. The device showed sensitivity and specificity of 90.3% and 91.9%, respectively, when compared to the ground truth established by the consensus of three U.S.-board certified senior radiologists.

 
“Cervical spine fractures are serious injuries that require prompt and appropriate medical attention, especially if the spinal cord is involved, so accurate diagnosis is essential,” said Cyril Di Grandi, co-founder and CEO of Avicenna.AI. “With CINA-CSpine, we aim to help reduce the delay between scan and interpretation, which is critical in the treatment of this condition.”
 
In June, the company received 510(k) clearance for a triage and notification AI tool that detects unsuspected vertebral compression fractures (VCFs) in patients undergoing chest or abdomen CT scans.