www.fdanews.com/articles/204230-radiobotics-nabs-510k-clearance-for-knee-osteoarthritis-software
Radiobotics Nabs 510(k) Clearance for Knee Osteoarthritis Software
September 2, 2021
Radiobotics has received the FDA’s 510(k) clearance for its RBknee artificial intelligence-based analysis tool designed to improve the accuracy of radiographic knee osteoarthritis diagnosis.
RBknee is intended for use in an orthopedic or a radiological setting, the Copenhagen-based company says.
The tool analyzes digital x-rays of knees and identifies common radiographic findings associated with osteoarthritis, using machine-learning algorithms to identify sclerosis and the narrowing of joint space in the knee.