We are delighted to announce that Radiobotics’ RBfracture™ has been CE-marked under MDR (European Medical Device Regulations) as a class IIa medical device, making Radiobotics among some of the first movers with this particular certification.
RBfracture is a new AI-powered product now cleared for sale in the EU to assist in detecting fractures in Emergency Medicine. Globally, 178 million fractures were registered in 2019. At the same time, missed fractures account for the vast majority of diagnostic errors in the emergency setting. This is particularly where RBfracture can add value, assisting as an extra pair of eyes and safety net, aiding in detecting if the patient has suffered a fracture.
This is supported by a study carried out in 2021, where RBfracture has shown to improve diagnostic accuracy when using RBfracture as a decision support tool, specifically for hip fractures, an often difficult case to diagnose. RBfracture assists both Clinicians and Radiology professionals in reviewing fracture x-rays and is built on the same innovative AI technology as Radiobotics’ other tools for MSK X-rays. This is an area of emergency medicine where the stakes are particularly high. As an example, hip fractures can be particularly devastating, with a one-year mortality rate of close to 30%. The pooled cost for treatment in a hospital for a hip fracture has been estimated to be US$10 075, and total health and social care costs for one hip fracture after 12 months amounted to a global mean of $43 669. Based on advanced computer vision and state-of-the-art machine learning methods, RBfracture, which covers the entire appendicular skeleton, can reduce errors and hold promise to reduce time to treatment and improve healthcare outcomes.
“We have already shown that emergency doctors find almost 50% more hip fractures when using RBfracture, thus enabling a faster diagnosis for a critical group of patients. I am thrilled that RBfracture is now certified against the high European standards on medical devices, demonstrating the necessary quality and safety. This is going to benefit many patients throughout Europe”
says Michael Lundemann Clinical Director at Radiobotics. The high quality of RBfractureTM is a result of a collaboration between Radiobotics and Virtual Radiologic (vRad), the leading U.S. teleradiology practice with 500 U.S. board-certified or eligible physicians. vRad delivers high-quality diagnostic imaging services to 2,100 facilities and radiology groups across the United States - represented in all 50 states.
“The RBfracture suite is trained on more than 100.000 X-rays from 1,300 facilities in the US and Europe. Data access has been enabled through a very successful and tight collaboration with vRad which will further be used to keep improving the product in the future”,
says Pavel Lisouski CTO & Co-founder at Radiobotics.
Medical Device Regulation (MDR) is the regulatory framework in the European Union. The MDR 2017/745 concerns the production and distribution of all medical devices and software that provides any kind of decision support. The MDR strengthens patient safety, and the standards help medical device companies develop recipes for how they can build their products in an as safe and effective manner as possible. This recipe book is called the quality management system or QMS. For further information see www.eur-lex.europa.eu and www.tuvsud.com
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