EU certification granted for AI algorithms for vertebral compression fracture quantification and cervical spine fracture detection.
MARSEILLE, France, June 5, 2025 /PRNewswire/ -- Medical imaging AI company Avicenna.AI today announced that it has received CE Mark certification for CINA-VCF Quantix, a new AI algorithm designed to detect and assess unsuspected vertebral compression fractures (VCFs) in patients undergoing CT scans for unrelated conditions. The company also secured CE Mark certification for CINA-CSpine, an AI tool designed to detect and triage cervical spine fractures from CT images.
The CE mark signifies that both products meet the stringent health and safety standards required by the European Union, enabling them to be deployed across the European Economic Area without additional regulatory barriers.
VCFs, often caused by bone deterioration due to osteoporosis, can lead to significant pain, deformity, and height loss. In the U.S. alone, approximately 750,000 adults suffer osteoporotic VCFs annually, but nearly two-thirds go undiagnosed, increasing the risk of further fractures and complications.
CINA-VCF Quantix is intended for patients aged 50 and older undergoing CT scans of the chest and/or abdomen for other conditions. The tool automatically labels vertebrae and calculates vertebral height loss ratios in the thoracic and lumbar spine. If a vertebral height loss ratio exceeds 20%-25%, indicating a moderate to severe VCF, CINA-VCF Quantix generates a passive notification, prompting radiologists to report early findings and supporting proactive patient care.
"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," said Cyril Di Grandi, co-founder and CEO of Avicenna.AI. "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."
Cervical spine fractures, typically caused by trauma, involve breaks in one or more of the seven cervical vertebrae in the neck. If the spinal cord is affected, these fractures can cause neurological damage or paralysis. Early diagnosis and treatment are critical to improving outcomes and minimizing long-term complications.
CINA-CSpine automatically flags suspected acute cervical spine fractures, alerting radiologists through their existing systems for faster diagnosis and intervention.
"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," said Di Grandi. "CINA-CSpine serves as a second pair of eyes, enhancing diagnostic confidence and ultimately improving patient outcomes across Europe."
All of Avicenna.AI's products are seamlessly integrated into radiologists' clinical workflow, automatically triggering and reporting algorithm results through the systems already used by radiologists. The company's product portfolio also includes AI tools for:
- Intracranial hemorrhage (CINA-ICH)
- Large vessel occlusion (CINA-LVO)
- Aortic dissection (CINA-AD)
- Pulmonary embolism (CINA-PE and CINA-iPE)
- Vertical compression fractures (CINA-VCF)
- And ASPECT Score for quantification of stroke severity (CINA-ASPECTS).
About Avicenna.AI
Founded in 2018, Avicenna.AI specializes in providing healthcare AI solutions that utilize deep learning to identify, detect, and quantify severe pathologies from CT medical images. Co-founded by Cyril Di Grandi, a successful entrepreneur who previously co-founded Olea Medical, and Dr. Peter Chang, an internationally recognized radiologist, and an expert in AI and deep learning, Avicenna.AI aims to accelerate therapeutic decision-making processes and enhance patient outcomes through its AI-based radiology solutions. For additional details, stay connected with us on social media and explore Avicenna.AI's website at www.avicenna.ai.
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