France-based medical imaging AI company Avicenna.AI has received CE mark certification for its spine imaging AI tools, CINA-VCF Quantix and CINA-CSpine.
The tools are designed to enhance the detection and assessment of vertebral compression fractures (VCFs) and cervical spine fractures, respectively, using CT scans.
The CE mark allows the deployment of imaging products across the European Economic Area without additional regulatory hurdles.
The CINA-VCF Quantix is intended for patients aged 50 and above who are undergoing CT scans for unrelated conditions.
It automatically labels vertebrae and calculates vertebral height loss ratios in the thoracic and lumbar spine.
If the height loss ratio exceeds 20%-25%, the tool generates a passive notification, prompting radiologists to report early findings and support proactive patient care.
CINA-CSpine automatically flags suspected acute cervical spine fractures, alerting radiologists through their existing systems for faster diagnosis and intervention.
Avicenna.AI co-founder and CEO Cyril Di Grandi said: “Osteoporotic vertebral fractures can have a profound impact on patients’ quality of life.
“The launch of CINA-VCF Quantix in Europe represents a major step forward in preventive care, empowering clinicians to intervene before minor fractures escalate.
“By encouraging the reporting of VCF presence and severity, CINA-VCF Quantix has the potential to make a real difference in long-term patient outcomes.”
Founded in 2018, Avicenna.AI specialises in healthcare AI solutions that use deep learning to identify, detect, and quantify severe pathologies from CT medical images.
The company aims to advance therapeutic decision-making processes and enhance patient outcomes through AI-based radiology solutions.
Its portfolio includes AI tools for intracranial haemorrhage, large vessel occlusion, aortic dissection, pulmonary embolism, and stroke severity quantification.
In July last year, Avicenna.AI received the European Union (EU) Medical Device Regulation (MDR) certificate for five of its AI-powered imaging algorithms.
The certification was granted by BSI Medical Devices, an EU Notified Body that provides quality management reviews and CE certifications for medical device makers worldwide.
Di Grandi added: “The launch of CINA-CSpine in the European market marks a significant step forward in trauma care.
“By reducing the time between scan and diagnosis, we’re helping radiologists catch cervical spine fractures faster and more reliably, a crucial advance when every minute counts.
“CINA-CSpine serves as a second pair of eyes, enhancing diagnostic confidence and ultimately improving patient outcomes across Europe.”
