The increasing demand for emergency imaging has led to a surge in the use of traditional X-rays, especially for assessing traumatic injuries. Conventional X-ray still remains the first radiological test for suspected fractures. Yet, identifying fractures in X-rays in the emergency room (ER) is challenging, particularly due to the constant influx of patients around the clock and the dependence on less experienced radiologists for initial assessments. Deep learning (DL) algorithms offer the potential to enhance fracture detection by radiologists and ER physicians. Now, a new generation of software based on DL technology can aid the accurate diagnosis of fractures and reduce diagnostic errors.

AZmed’s (Paris, France) Rayvolve is a computer-assisted detection and diagnosis software device capable of detecting fractures on standard X-rays, allowing doctors to save time and increase diagnosis accuracy. Rayvolve detects and automatically ranks X-rays that show signs of abnormalities, allowing radiologists to prioritize these cases in their workflow. Rayvolve has now achieved 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its use in pediatric fracture detection, following its prior clearance for adult applications. This approval was bolstered by an independent study that affirmed Rayvolve's effectiveness in a clinical setting, analyzing a dataset of 3,000 pediatric radiographs. The study highlighted Rayvolve's high sensitivity (96%) and specificity (86%), marking it as one of the most proficient tools for assisting radiologists in spotting fractures in children, with an Area Under the Curve (AUC) of 94%.

This FDA clearance marks a significant expansion opportunity for AZmed in the U.S. medical imaging market. The company's strategy to introduce Rayvolve to more U.S. healthcare providers is aimed at refining traditional diagnostic approaches by accelerating fracture detection and mitigating the effects of clinician fatigue and workload. As Rayvolve becomes more widely adopted, AZmed continues to invest in the development of AI-based, clinically validated technologies that enhance both patient care and healthcare 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." 

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