FDA Clears Avicenna.AI’s Vertebral Fracture Detector

FDA has cleared an Avicenna.AI 510(k) for its CINA-VCF, a triage and notification artificial intelligence tool for detecting unsuspected vertebral compression fractures (VCFs) in patients undergoing chest or abdomen CT scans. “Often resulting from the deterioration of bone structure (osteoporosis), VCFs can cause significant pain, deformity, and height loss,” the company says, adding that early detection can help prevent further bone density loss and additional fractures.

The CINA-VCF algorithm identifies and prioritizes vertebral compression fractures detected during routine CT scans for patients undergoing medical imaging for entirely different health conditions, according to the company. The tool was validated based on 474 CT scans (performed for other clinical indications than for VCF evaluation) acquired on 38 different scanner models from four different manufacturers, demonstrating “excellent sensitivity and specificity results,” it adds.