Avicenna.AI has been granted 510(k) clearance by the US Food and Drug Administration (FDA) for its latest artificial intelligence (AI) tool, CINA-CSpine, designed to assist in detecting cervical spine fractures from CT images.
The tool utilises advanced AI techniques such as deep learning and machine learning to quickly identify and flag potential life-threatening conditions.
Cervical spine fractures, which occur in the neck vertebrae, are typically caused by traumatic injuries. They can lead to serious complications such as spinal cord damage, resulting in neurological impairment or, in severe cases, paralysis.
Early detection is crucial for effective treatment and to reduce the risk of long-term complications. CINA-CSpine helps radiologists by automatically identifying suspected cervical spine fractures and sending alerts through the clinical systems they already use.
Avicenna.AI co-founder and CEO Cyril Di Grandi said: “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.
“With CINA-CSpine, we aim to help reduce the delay between scan and interpretation, which is critical in the treatment of this condition.”
The CINA-CSpine tool is said to offer radiologists an additional layer of analysis to help mitigate the risk of missing critical cervical spine injuries.
It has been validated using over 300 non-contrast CT scans sourced from both the US and Europe. The scans were acquired using 36 different scanner models, spanning five vendors.
In clinical trials, the tool demonstrated a sensitivity rate of 90.3% and a specificity rate of 91.9%, compared with the consensus of three US-board certified senior radiologists, said Avicenna.AI.
Di Grandi said: “These results demonstrate that our CINA-CSpine algorithm is capable of providing prompt and accurate findings that could positively guide physicians towards better assessments and improved patient outcomes.”
CINA-CSpine is one of several AI tools developed by Avicenna.AI to receive FDA clearance. All the company’s tools are said to be fully integrated into the existing workflows of radiologists, ensuring that AI-generated findings are seamlessly incorporated into their regular processes.
