Avicenna.AI Gains FDA Clearance for CINA-VCF AI Detection Tool

Avicenna.AI has received 510(k) clearance from the FDA for CINA-VCF, a triage and notification AI tool that detects unsuspected vertebral compression fractures (VCFs) in patients undergoing chest or abdomen CT scans.
 
CINA-VCF identifies, prioritizes, and notifies clinicians of vertebral compression fractures detected during CT scans for patients undergoing medical imaging for entirely different health conditions. The tool aims to prevent bone density loss and fractures by addressing VCFs before they multiply.
 
“Osteoporosis is a global burden affecting millions, especially postmenopausal women, and often goes unnoticed until symptoms like pain and loss of mobility appear,” said Cyril Di Grandi, co-founder and CEO of Avicenna.AI. “By detecting vertebral compression fractures early, we aim to help patients maintain better mobility and independence, enhance the well-being of those at risk, and reduce the burden on healthcare systems worldwide. We have also partnered with the International Osteoporosis Foundation to increase awareness about this debilitating condition.”
 
CINA-VCF was validated on 474 CT scans (performed for other clinical indications than for VCF evaluation) on 38 different scanner models from four different manufacturers, achieving excellent sensitivity and specificity results.
 
CINA-VCF is the latest tool from Avicenna.AI to secure FDA clearance, joining its AI solutions for automatic detection of a host of conditions from CT imaging.