BoneView is the first AI solution to receive FDA clearance for pediatric use in fracture detection.
French MedTech start-up Gleamer announced today that its AI-powered fracture detection solution, BoneView, has received FDA clearance for use in children over two years old. This marks a significant milestone for the company and the industry as a whole, as BoneView is now the first and only AI-powered solution approved for adult and pediatric population fracture detection.
BoneView uses advanced AI algorithms to aid radiologists, orthopedic surgeons, emergency physicians, rheumatologists, family physicians, and physician assistants in diagnosing fractures in their patients quickly and accurately, improving patient outcomes and reducing the risk of misdiagnosis.
A recent study published in Skeletal Radiology, “Automated detection of acute appendicular skeletal fractures in pediatric patients using deep learning,” already attests to the effectiveness of BoneView on US pediatric data with a sensitivity of 91% for children and teenagers.
Christian Allouche, CEO of Gleamer, expressed excitement about BoneView’s FDA approval for use in pediatric patients, calling it a significant advancement in their efforts to enhance fracture detection and diagnosis through AI. Gleamer believes BoneView can positively impact patients and healthcare providers and looks forward to its increased adoption.
BoneView is one of several AI-powered solutions developed by Gleamer to help improve patient care and outcomes. The company is poised to become a leader in AI-powered medical solutions with this new FDA approval. Just a few days after receiving MDR CE Certification for two brand-new solutions, BoneView Measurements and BoneView Bone Age, Gleamer continues to innovate and advance the field of medical AI.
BoneView analyzes more than seven million images worldwide annually and is deployed in more than 30 countries across Europe, the Middle East, Asia-Pacific, and North America. Over 5000 radiologists and emergency physicians now rely on BoneView in their clinical routines. The solution is available in the U.S. through Gleamer and other platforms, including Fujifilm, Aidoc, Ferrum Health, and Blackford Analysis.
BoneView, our first clinical AI application, has become a global bone trauma X-ray interpretation standard, recognized for its scientific excellence. It pinpoints fractures, effusions, dislocations, and bone lesions efficiently. Recognized for its scientific rigor with publications in top-tier peer-reviewed journals, its clinical study won the prestigious 2022 Alexander Margulis Award for scientific excellence.Learn more
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