A Danish startup has received FDA clearance for its knee osteoarthritis algorithm.
Radiobotics has created the RBKnee algorithm, an AI-based analysis tool aimed at improving the efficiency and accuracy of radiographic knee osteoarthritis diagnosis.
Osteoarthritis (OA) is a very common joint disease, with 10 per cent of the world’s population aged over 60 estimated to have joint-related problems that can be attributed to arthritis, according to the WHO Scientific Group on Rheumatic Disease.
Radiography is commonly used to support the diagnosis and track progression of the disease, but demand for medical imaging is soaring, with a global shortage of radiologists.
The osteoarthritis algorithm RBknee works by analysing digital X-rays of knees and identifying common radiographic findings associated with the diagnosis of OA. By supporting clinicians with clinically validated AI technology, the AI-led innovation has the potential to save time and money as well as improving clinical outcomes through consistent, objective, and accurate measurements and analysis.
“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,” says Ayse McCracken, chair of the board at Radiobotics, which was founded in 2017.
“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.”
RBknee can identify presence or absence of osteophytes, subchondral sclerosis, joint space narrowing, and conclude on the presence or absence of OA by 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 clinical 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.
“RBknee is our first product with FDA clearance accompanied with a European MDR certification earlier this year,” says co-founder and president of Radiobotics, Stine Mølgaard Sørensen.
“This emphasizes the potential of our technology and our AI-based solutions continue to demonstrate quality and safety. We are ambitious on behalf of the development of the field of radiology and orthopaedics and the FDA clearance is important to both Radiobotics as well as patients in not only Europe but now also in the US.”