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The artificial intelligence (AI)-enabled software, which has a documented 91 percent sensitivity rate for detecting pediatric fractures, is reportedly the first AI fracture detection modality to receive FDA 510(k) clearance for use in the pediatric population.
The Food and Drug Administration (FDA) has granted 510(k) clearance for the use of BoneView (Gleamer), an artificial intelligence (AI) software that helps detect fractures on X-ray, in patients over two years of age.1
In a recently published study involving 300 pediatric patients, researchers demonstrated a 91.3 percent sensitivity rate and a 90 percent sensitivity rate for fracture detection.2
Christian Allouche, the chief executive officer of Gleamer, called the pediatric clearance a significant advance in the company’s efforts to improve fracture detection and diagnosis through the use of AI.1
Employing deep learning algorithms, the BoneView software analyzes X-rays and highlights regions of interest for suspected fractures that are sent to the radiologist for confirmation, according to Gleamer. The company said BoneView is the only AI fracture detection software to have FDA clearance for use in adults and pediatric patients.
The FDA initially granted BoneView 510(k) clearance in March 2022 for fracture detection in adults.3