AZmed’s Rayvolve Wins FDA Nod to Detect Pediatric Fractures

AZmed, a European startup focused on artificial intelligence (AI) for medical imaging, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Rayvolve system to detect fractures on pediatric X-rays.
 
This approval comes two years after the company gained FDA clearance for adult fracture detection. The pediatric clearance was backed by an independent study conducted with SimonMed Imaging, a U.S.-based outpatient imaging provider.
 
Bench testing done in partnership with SimonMed confirmed Rayvolve’s efficacy in clinical settings. The study involved a dataset of 3,000 pediatric radiographs and showed 96% sensitivity with 86% specificity. This makes Rayvolve one of the most effective software to help radiologists spot fractures in children, with a 94% Area Under the Curve (AUC).
 
By bringing Rayvolve to more U.S. clinicians, AZmed aims to improve traditional methods by focusing on faster fracture detection and lowering the impacts of fatigue and workload on healthcare professionals. As it gains traction, AZmed said its focused on building AI-driven, clinically validated innovations to improve care and operational efficiency.
 
“The 510(k) clearance reflects our commitment to meeting the needs of healthcare professionals,” said Julien Vidal, 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.”

---

READ MORE: An exclusive article written by AZmed CEO Julien Vidal

---

“We are proud to have contributed to validating Rayvolve’s effectiveness,” added Dr. Sean Raj, chief innovation officer of SimonMed Imaging. “This study underscores the transformative potential of AI as an indispensable diagnostic tool for pediatric fracture detection.”