GLEAMER Granted FDA Clearance for AI Fracture Detection

By Julie A. Vetalice

GLEAMER Granted FDA Clearance for AI Fracture Detection

GLEAMER gained FDA clearance to market BoneView® AI software for use by U.S. healthcare specialists to aid in diagnosing fractures and traumatic injuries on x-rays. The system was also approved by the CE Mark in Europe in 2020.

Studies indicate that BoneView was shown to help detect and localize fractures over the entire appendicular skeleton, rib cage, thoracic and lumbar spine, improving sensitivity and specificity, while reducing reading time. 

GLEAMER developed BoneView to aid radiologists, orthopedic surgeons, emergency physicians, rheumatologists, family physicians and physician assistants, all of whom read x-rays in clinical practice to diagnose fractures in their patients. BoneView detects fractures in x-ray images and submits them to radiologists for final validation, providing healthcare professionals with a reliable, time-saving and user-friendly tool. The BoneView AI algorithm is cleared as a CADe/CADx (computer assisted detection and diagnosis) by FDA and highlights regions of interest with bounding boxes around areas where fractures are suspected, so radiologists can prioritize reading those x-rays.

Study results showed that BoneView AI assistance provided a 10.4% improvement of fracture detection sensitivity and shortened the radiograph reading time by 6.3 seconds per patient.

Across the six types of specialists participating in the study, the combination of artificial intelligence and health professionals' interpretations lowered the false negative rate (undetected fractures) on x-rays by 29%, while reducing reading time by 15% on exams specifically selected for their difficulty. BoneView also improved the specificity of fracture detection by radiologists and non-radiologists involving many anatomical locations, including foot/ankle, knee/leg, hip/pelvis, hand/wrist, elbow/arm, shoulder/clavicle, rib cage and thoracolumbar spine.

Traumatic skeletal injuries are a leading source of consultation in emergency departments, representing one-third of annual visits. Fracture interpretation errors can represent up to 24 percent of harmful diagnostic errors seen in the ER and are more common during the evening and overnight hours, most likely related to non-expert reading and fatigue.

To date, BoneView has analyzed more than three million images around the world and is deployed in more than 13 countries across Europe, the Middle East, Asia-Pacific and North America. More than 3,500 radiologists and emergency physicians now rely on BoneView in their clinical routines. The solution is now available in the U.S. directly via GLEAMER and through other platforms including Fujifilm, Aidoc, Ferrum Health, Blackford Analysis.


Tags: 510(k) Clearance, Regulatory