FDA clears Avicenna.AI’s fracture detection software

Avicenna.AI has secured clearance from the U.S. Food and Drug Administration (FDA) for CINA-VCF, a triage and notification AI tool that detects vertebral compression fractures (VCFs) in patients undergoing chest or abdomen CT scans.

The CINA-VCF algorithm identifies and prioritizes vertebral compression fractures during routine CT scans for different health conditions and notifies clinicians within seconds, according to the company. 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, Avicenna.AI said.

In the U.S., approximately 750,000 adults suffer from osteoporotic VCFs each year, but around two-thirds of those go undetected or unreported, the company noted.

Page 1 of 368
Next Page