Radiobotics’ RBfracture has been CE-marked under MDR (European Medical Device Regulations) as a class IIa medical device, positioning the Danish healthtech company among some of the first with this particular certification.

Rubber stamp-CE marking - 3d illustration

RBfracture is a new AI-powered product now cleared for sale in the EU. This marks a new phase for Radiobotics as the company enters Emergency Medicine to assist in detecting fractures in trauma patients. Globally, 178 million fractures were registered in 2019. At the same time, missed fractures account for a vast majority of diagnostic errors in the emergency setting.

This is particularly where Radiobotics’ RBfracture can add value, assisting as an extra pair of eyes, aiding in detecting if the patient has suffered a fracture.

A study on hip fractures has shown improved diagnostic accuracy when using RBfracture as a decision support tool. The product assists trauma professionals in reviewing fracture X-rays and is built on the same AI technology as Radiobotics’ other tools for MSK X-rays. Based on advanced computer vision and machine learning methods, RBfracture which covers the entire appendicular skeleton.

Michael Lundemann, clinical director at Radiobotics, said: “We have already shown that emergency doctors find almost 50% more of the hip fractures that would otherwise have been missed 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.”

The high quality of RBfracture 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.

Pavel Lisouski, CTO & co-founder at Radiobotics, said: “RBfracture is trained on more than 100.000 X-rays from 1,300 different facilities in the U.S. and Europe. Data access has been enabled through a very successful and tight collaboration with vRad which further will be used to keep improving the product in the future.” 

 Radiobotics’ ambition is to contribute to the development of the healthcare industry, particularly in radiology. Therefore, Radiobotics is continuously expanding its portfolio by adding more products for the assessment of MSK X-rays. The goal of the trauma suite is to build AI technology that will enable faster patient treatment and, in the future, will be robust enough to efficiently remove the need for time-consuming secondary review, thereby filling the gap for much-needed radiology staff.

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