FDA clears AI-driven algorithm diagnosis for knees

Danish Health Startup Radiobotics Receives FDA Clearance for AI-Driven Knee Algorithm (TechTimes)

Radiobotics, the Danish health tech startup, has announced securing a 510(k) clearance from the US Food and Drug Administration (FDA) for its RBknee algorithm and AI-driven knee osteoarthritis algorithm.

The proprietary algorithm by Radiobotics is an AI-driven analysis tool aimed at improving the accuracy and efficiency of radiographic knee osteoarthritis diagnosis. RBknee analyzes digital x-rays and uses its algorithm to return diagnoses. This tool creates the potential to save time and money in a healthcare system experiencing a growing demand for medical images against a shortage of radiologists.

RBknee(Photo : Radiobotics)

Addressing the Larger Challenges of OA

Osteoarthritis remains one of the most common joint diseases, affecting knees and leading to many disabilities worldwide. For example, in the United States alone, the Centers for Disease Control and Prevention (CDC) notes that more than 32.5 million adults suffer from osteoarthritis. Additionally, there are multiple risk factors for the diseases, such as joint overuse, age, and genetics.

One of the most common medical procedures used to diagnose and track the progression of the disease is radiography or x-ray analysis. Unfortunately, while the demand for medical imaging continues to increase, the healthcare system is reeling from a global shortage of radiologists.

With the new solution from Radiobotics, its AI-driven tool could analyze digital x-ray of knees and identify common radiographic signs and findings associated with OA diagnoses. RBknee was designed for use in standard orthopedic and radiologic settings, where X-ray images are read to determine a diagnosis and potential treatment for the OA patient. By supporting clinicians with a clinically validated AI tool, RBknee can potentially help save time and money and improve outcomes through consistent, accurate, and objective 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 Radiobotics Chair of the Board Ayse McCracken in a company press release. She notes that as the global population ages, demand for healthcare will only accelerate. The FDA clearing for RBknee shows that Radiobotics is now ready for the next step in their support of the digitization of the health industry.

Among the capabilities of the RBknee is in checking the presence or absence of osteophytes, joint space narrowing, subchondral sclerosis, and even conclude the presence of osteoarthritis. Concerning joint space, RBknee can accurately measure joint space in both knee compartments.

About Radiobotics

Originally founded in Denmark in 2017, Radiobotics has grown into multiple award-winning health tech companies. It has developed an innovative AI-driven tool specifically designed for x-ray analysis, with an additional focus on musculoskeletal radiology. Based on the latest computer vision and machine learning methods, RBknee generates fully automated objective text and visual reports.

Additionally, its visual overlays will be supporting consistency over time, enabling fast and accurate interpretation of x-ray images. This tool will not only help radiologists and orthopedics but will also reduce the wait time for patients.