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FDA Grants AI Platform Expanded Clearance for Pediatric Fracture Detection on X-Rays
The AI-enabled software Rayvolve reportedly demonstrated a 96 percent sensitivity rate for diagnosing pediatric fractures in a recent study involving 3,000 patients.
The Food and Drug Administration (FDA) has granted an expanded (510)k clearance for the artificial intelligence (AI)-powered software Rayvolve for the detection of pediatric fractures.1
Noting a recent study examining the use of Rayvolve for diagnosing pediatric fractures on X-rays, AZMed, the manufacturer of Rayvolve, said the AI platform had a 96 percent sensitivity rate, 86 percent specificity and a 94 percent area under the curve (AUC).1
In a study involving over 3,000 cases of pediatric fractures, researchers found that the AI-powered software Rayvolve, which recently gained a FDA clearannce for pediatric fracture detection, had a 96 percent sensitivity rate and a 94 percent area under the curve (AUC). (Image courtesy of AZmed.)
The Rayvolve software previously garnered FDA clearance for adult fracture detection on radiographs. At the 2023 RSNA conference, researchers found that Rayvolve could facilitate a sixfold reduction in turnaround time from image acquisition to the final radiology report.2
"The 510(k) clearance reflects our commitment to meeting the needs of health-care professionals," said Julien Vidal, the CEO of AZmed. "We are excited to extend our innovation to pediatric care, empowering clinicians with advanced tools to achieve the best outcomes for their patients."
References
1. AZMed. AZMed secures FDA 510(k) clearance for Rayvolve in pediatric fracture detection through study with SimonMed Imaging, expanding its AI-powered medical imaging solutions. PR Newswire. Available at: https://www.prnewswire.com/news-releases/azmed-secures-fda-510k-clearance-for-rayvolve-in-pediatric-fracture-detection-through-study-with-simonmed-imaging-expanding-its-ai-powered-medical-imaging-solutions-302236044.html . Published September 3, 2024. Accessed September 3, 2024.
2. Hall J. AI facilitates nearly 83 percent improvement in turnaround time for fracture X-rays. Available at: https://www.diagnosticimaging.com/view/ai-nearly-83-percent-improvement-turnaround-time-fracture-x-rays . Published December 19, 2023. Accessed September 3, 2024.
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