France-based medical imaging AI company Avicenna.AI has received the US Food and Drug Administration (FDA) 510(k) approval for its new triage and notification AI tool, CINA-VCF.
CINA-VCF is designed to detect unsuspected vertebral compression fractures (VCFs) in patients who are undergoing chest or abdomen CT scans.
Its algorithm identifies and prioritises VCFs detected during routine CT scans for patients undergoing medical imaging for different health conditions and informs clinicians immediately.
The medical AI company validated the tool on 474 CT scans, performed for other clinical indications than for VCF, on 38 different scanner models from four different manufacturers.
In the examinations, the CINA-VCF solution achieved superior sensitivity and specificity results.
Avicenna.AI co-founder and CEO Cyril Di Grandi said: “Osteoporosis is a global burden affecting millions, especially postmenopausal women, and often goes unnoticed until symptoms like pain and loss of mobility appear.
“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.”
Avicenna.AI said that CINA-VCF is its latest tool to secure FDA approval, alongside its AI solutions for automatic detection of a host of conditions from CT imaging.
Its other AI tools include CINA-ICH for intracranial haemorrhage, CINA-LVO for large vessel occlusion, CINA-AD for aortic dissection, CINA-PE for pulmonary embolism, and CINA-ASPECTS for quantification of stroke severity.
Also, it is the second FDA-approved tool for incidental findings, after CINA-iPE, which identifies unsuspected cases of pulmonary embolism in oncology patients.
By enabling early detection of VCFs, the AI solution aims to help prevent further bone density loss and additional fractures, enhancing patient care and outcomes.
The CINA-VCF tool helps address vertebral fractures before they multiply, reducing the risk of complications and potentially lowering medical expenses, said the medical AI company.
