
Paris, France – March 3 2023
GLEAMER, a leading healthcare technology company, is proud to announce the MDR CE Certification of two new solutions: BoneView Measurements and BoneView Bone Age. These solutions are designed to optimize readers’ workflow and improve accuracy.
The EU-MDR is a set of regulations established by the European Commission to improve the safety and quality of medical devices and ensure public health and patient safety through enhanced transparency for patients.
BoneView Measurements provides automated MSK measurements for the pelvis, leg, feet, and spine, intending to save radiologists time and automatically generate a standardized report for orthopedic surgeons.
BoneView Bone Age automates Greulich & Pyle-based bone age assessment, which helps overcome the considerable reader variability of manual ratings. The solution is a breakthrough in healthcare technology and will significantly benefit healthcare providers and patients alike.
“We are thrilled to announce that our AI solutions have been certified as Class IIa medical devices under EU-MDR,” said Christian Allouche, CEO of GLEAMER. “We are confident they will revolutionize the workflow of many centers.”
To learn more about these solutions and their clinical validation studies, request a demo from GLEAMER. The studies’ abstract will also be presented at the ECR 2023.
About GLEAMER
GLEAMER revolutionizes Radiology with AI solutions that embody medical-grade expertise. The company aims to aid imaging users in achieving accurate diagnoses for all patients while improving efficiency. With AI Companions directly integrated into the users’ standard reading environment, diagnostic accuracy in X-ray imaging is augmented through concurrent automated and transparent readings. Currently, GLEAMER’s solutions serve over 550 institutions in 24 countries. Learn more at www.GLEAMER.ai.