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Avicenna.AI secures FDA clearance for AI detection of vertebral compression fractures

Medical imaging AI company receives approval for algorithm enabling opportunistic detection and triage of vertebral compression fractures.

La Ciotat, FRANCE, June 12, 2024 /PRNewswire/ — Avicenna.AI, a leading medical imaging AI company, has received 510(k) clearance from the US Food and Drug Administration (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.

Often resulting from the deterioration of bone structure (osteoporosis), VCFs can cause significant pain, deformity, and height loss. In the USA, approximately 750,000 adults suffer from osteoporotic VCFs each year, but around two-thirds of those go undetected or unreported.

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, notifying clinicians within seconds. The tool was validated on 474 CT scans (performed for other clinical indications than for VCF evaluation) acquired on 38 different scanner models from four different manufacturers, achieving excellent sensitivity and specificity results.

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