Avicenna.AI has gained FDA approval for AI detection of vertebral compression fractures

Thursday, June 13, 2024

Avicenna.AI, a leading company in medical imaging AI, has received 510(k) clearance from the FDA for CINA-VCF, an AI tool designed to detect vertebral compression fractures (VCFs) during chest or abdomen CT scans.

These fractures, often caused by osteoporosis, can result in significant pain, deformity, and height loss. In the US, a large number of osteoporotic VCF cases remain undetected each year.

CINA-VCF identifies and prioritizes VCFs incidentally found during routine CT scans performed for other health conditions, providing immediate notifications to clinicians.

The algorithm was validated on 474 CT scans from 38 scanner models across four manufacturers, demonstrating excellent sensitivity and specificity.

Early detection with CINA-VCF aims to prevent further bone density loss and fractures, potentially improving patient outcomes and reducing healthcare costs.

The tool's importance in enhancing mobility and independence, particularly for postmenopausal women who are at higher risk of osteoporosis.

In addition to CINA-VCF, Avicenna.AI has developed other FDA-cleared AI tools such as CINA-iPE for identifying pulmonary embolism in oncology patients.

These tools seamlessly integrate into radiologists' workflows, automatically generating and reporting results through existing clinical systems.

Through collaboration with the International Osteoporosis Foundation, Avicenna.AI aims to raise awareness about osteoporosis and expand access to early detection with CINA-VCF, reflecting its commitment to improving global healthcare.








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