Imidex announced that it received FDA 510(k) clearance for its flagship, AI-powered VisiRad XR software product.
VisiRad XR analyzes chest X-rays and highlights possible lung nodules and masses. It employs state-of-the-art machine learning techniques developed using curated training data from around the world.
According to Imidex, the software offers clinicians a closer look at often-overlooked lung lesions. This could enable the identification of future lung cancers in outpatient and emergency department settings.
“Radiologists are looking for solutions to help elevate their performance and reduce burnout,” said Dr. Raj Chopra, Imidex chief medical officer. “With volumes increasing and staffing decreasing, tools like VisiRad XR are beneficial not only for patient care, but for helping radiologists continue to practice to their full potential.”
More about the Imidex VisiRad XR solution
VisiRad XR offers a turnkey solution that plugs into the current radiology workflow, Imidex says. It routs images with AI-detected lesions back to radiologists within their native viewing environment. This gives them the opportunity to see VisiRad XR’s results right behind the primary image for interpretation.
Imidex said VisiRad requires no additional testing orders and seeks to increase the number of detected lung nodules and masses in patients seen through routine care.
The company cites two studies that supported VisiRad in its FDA 510(k) submission. A retrospective study utilizing over 11,000 patient images detected lung nodules and masses at 83% sensitivity. This included a fixed false positives per image rate and a fixed device operating threshold. Imidex said this demonstrates the potential to identify an additional 750 nodules or masses a year based on an average of 50,000 annual chest X-rays in the U.S.
Clinical evaluation of VisiRad XR used 600 images and 24 radiologists across the U.S. The company says its software improved each reader’s ability to detect pulmonary nodules and masses within chest X-rays. This study showed statistically significant improvement in area under the curve of the receiver operating curve. It also demonstrated increased sensitivity across all readers.
“Achieving this clearance enables us to provide a tool to radiologists that can have a tangible benefit in getting more patients the care they need,” said Richard Vlasimsky, CEO of Imidex, “Chest X-rays are the most common radiological procedure in the world, which means that the opportunity for VisiRad XR’s impact is enormous. We’re thrilled to take the next step forward in our mission to save lives lost to lung cancer.”