Summary: AZmed’s Rayvolve software has received FDA clearance for detecting fractures in pediatric X-rays, following a successful study showing high accuracy.

Key Takeaways

  • FDA Clearance: AZmed’s Rayvolve software received U.S. FDA 510(k) clearance for detecting fractures in pediatric X-rays, following its earlier approval for adult fractures.
  • High Accuracy: A SimonMed Imaging study of 3,000 pediatric X-rays demonstrated Rayvolve’s high sensitivity (96%) and specificity (86%), reinforcing its effectiveness in clinical settings.
  • Market Expansion: AZmed plans to expand Rayvolve’s use in the U.S. market, aiming to help radiologists reduce workload, improve diagnostic accuracy, and enhance patient care through AI-driven innovations.

————————————————————————————————————————————————————

AZmed announces that its Rayvolve solution has received U.S. FDA 510(k) clearance for detecting fractures on pediatric X-rays. Following prior approval for adult fractures, Rayvolve was cleared based on a SimonMed Imaging study of 3,000 pediatric X-rays. The software showed 96% sensitivity, 86% specificity, and a 94% Area Under the Curve in clinical settings, enhancing radiologists’ ability to detect fractures in children efficiently.

“The 510(k) clearance reflects our commitment to meeting the needs of healthcare professionals,” says 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.”

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

AZmed is expanding Rayvolve’s use in the U.S. market to help radiologists reduce workload and improve accuracy, particularly in pediatric cases. The company plans to introduce Rayvolve to more healthcare providers to enhance diagnostic methods by enabling quicker fracture detection and reducing clinician fatigue. AZmed continues to focus on developing AI-driven innovations to improve patient care and operational efficiency across healthcare settings.