CE mark granted for AI-based MSK interpretation aid

A Danish healthtech company has been cleared for European sales of AI software aimed at helping trauma physicians detect and classify fractures.

Copenhagen-based Radiobiotics says it developed the product, called RBfracture, using X-rays from 1,300 care sites in Europe and the U.S., where the company has been collaborating on technology with the Minnesota-based teleradiology giant vRad (aka Virtual Radiologic).

By receiving the CE mark under MDR (European Medical Device Regulations) as a class IIa medical device, RBfracture extends Radiobiotics’ reach to cover all upper and lower extremities with AI-based clinical decision-support mechanisms, according to a Radiobiotics announcement emailed to the press June 29.

Radiobiotics says it plans to continue expanding its portfolio of MSK X-ray diagnostic products, of which RBfracture is one.  

“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,” the company states in the June 29 news release.

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