Today, we are pleased to announce the achievement of a major milestone in Radiobotics history:
The U.S. Food and Drug Administration (FDA) announces the 510(k) clearance of Radiobotics’ RBknee™ product, an AI based analysis tool aimed at improving the efficiency and accuracy of radiographic knee osteoarthritis diagnosis.
“If you look at the increase in demand for services for radiologists and the rate at which radiologists are burning out, we've got a huge problem. As the global population ages, the demand for health care services is only going to accelerate, and with the first product FDA cleared we’re now ready for the next step in our contribution to the digitization of the health industry and I’m very proud of all the hard work the team has put into it”,
The osteoarthritis (OA) product RBknee™ from Radiobotics works by analyzing digital x-rays of knees and identifying common radiographic findings associated with the diagnosis of OA, which is a very common joint disease, affecting knees and it is a major cause of disability worldwide. Ten percent of the world’s population above 60 years, are estimated to have joint related problems that can be attributed to arthritis, by the WHO Scientific Group on Rheumatic Disease.
RBknee™ is intended for use in an orthopedic or a radiological setting, where the x-ray is read in order to determine the diagnosis and treatment of OA. By supporting clinicians with clinically validated AI technology, RBknee™ has the potential to save time and money as well as improving clinical outcomes through consistent, objective and accurate measurements and analysis.
RBknee™ can identify presence or absence of osteophytes, subchondral sclerosis, and joint space narrowing using proprietary machine learning algorithms. Furthermore, RBknee™ can accurately measure the joint space width in both compartments of the knee.
The software is approved on the basis of rigorous testing and clinically validation of the algorithms, showing high sensitivity and specificity on the identification of findings, and a high precision of the measurements of the device when evaluated on an unseen dataset.
“We are proud of this achievement. Getting FDA clearance was always part of our commitment to prove that our product can be used safely at any hospital or clinic across the US. Combined with an European MDR certification and CE marking, it reaffirms that we live up to the highest standards and it motivates us to keep working hard to help hospitals and the healthcare industry to move towards a more digitalized future”