Avicenna.AI’s AI tool CINA-CSpine receives FDA clearance for cervical spine fracture detection

Avicenna.AI has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its new artificial intelligence (AI) tool, CINA-CSpine, which is specifically designed to detect cervical spine fractures from CT images. This development marks a significant step forward in medical imaging, as CINA-CSpine aims to assist radiologists by identifying and flagging potential fractures in the neck vertebrae quickly, using deep learning and machine learning techniques.

AI to Accelerate Diagnosis of Life-Threatening Cervical Injuries

Cervical spine fractures, often caused by traumatic injuries, can lead to severe complications, including spinal cord damage, neurological impairment, and even paralysis. The ability to detect these injuries early is vital for effective treatment and to prevent long-term damage. The CINA-CSpine tool works by automatically identifying possible cervical spine fractures, alerting radiologists through clinical systems they already use.

Cyril Di Grandi, co-founder and CEO of Avicenna.AI, highlighted the critical nature of early detection in cervical spine injuries, particularly in cases where the spinal cord is at risk. He pointed out that the CINA-CSpine tool could help reduce delays in diagnosis, potentially improving patient outcomes. He emphasised that the tool provides radiologists with an additional layer of analysis, helping to ensure that critical cervical spine injuries are not missed.

Proven Accuracy with Global Validation

The effectiveness of CINA-CSpine was demonstrated through validation involving more than 300 non-contrast CT scans, collected from both the US and Europe. The scans came from 36 different scanner models supplied by five vendors, making the results widely applicable. During clinical trials, CINA-CSpine showed a sensitivity rate of 90.3% and a specificity rate of 91.9%, based on the consensus of three senior US-board-certified radiologists.

Di Grandi noted that these results illustrate the tool’s ability to provide fast and accurate assessments, potentially improving patient outcomes by guiding physicians in their diagnoses. The tool’s high accuracy, combined with its seamless integration into existing radiological workflows, makes it a valuable asset in the early detection of life-threatening injuries.

A Growing Suite of AI Tools

CINA-CSpine is part of a growing portfolio of AI-driven diagnostic tools developed by Avicenna.AI, several of which have already received FDA clearance. The company’s tools are fully integrated into radiologists’ workflows, ensuring that the AI findings are naturally incorporated into the diagnostic process. This approach allows radiologists to maintain their existing procedures while benefiting from AI-enhanced insights, ultimately supporting better patient care.

Avicenna.AI’s FDA-cleared CINA-CSpine tool is poised to play a vital role in the early detection of cervical spine fractures. By using advanced AI to assist radiologists, the tool aims to reduce diagnostic delays and improve patient outcomes, offering an innovative solution for identifying potentially life-threatening injuries. With its demonstrated accuracy and seamless workflow integration, CINA-CSpine is set to become a critical resource for medical professionals in the field of diagnostic imaging.