European MedTech startup AZmed, recognized as a leading company in AI for medical imaging, today announced that its Rayvolve solution has received 510(k) clearance from the Food and Drug Administration (FDA) for detecting fractures on pediatric X-rays. This milestone comes two years after receiving FDA clearance for adult fracture detection, positioning Rayvolve as a top-performing solution for detecting fractures in adult and pediatric patients. The clearance was supported by an independent study conducted with SimonMed Imaging, one of the largest outpatient imaging providers in the U.S.
“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.”
Through rigorous bench testing, the study with SimonMed Imaging confirmed Rayvolve’s efficacy in clinical settings, further validating AZmed’s commitment to collaborating with healthcare leaders to advance medical imaging technology. Involving a dataset of 3,000 pediatric radiographs, the study demonstrated Rayvolve’s high sensitivity (96%) and specificity (86%), making it one of the most effective software for assisting radiologists in detecting fractures in children, with an Area Under the Curve (AUC) of 94%.
“We are proud to have contributed to validating Rayvolve’s effectiveness,” said 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.”
For AZmed, obtaining FDA clearance opens a growth opportunity in the U.S. medical imaging market. The plan to introduce Rayvolve to more U.S. healthcare professionals aims to enhance traditional methods by focusing on quicker fracture detection and reducing the impact of fatigue and workload on clinicians. As Rayvolve gains traction, AZmed remains focused on developing AI-driven, clinically validated innovations that improve patient care and operational efficiency.
