IMIDEX, a medical device company developing AI-based solutions for lung cancer, has received the US Food and Drug Administration (FDA) 510(k) approval for its VisiRad XR device.

VisiRad XR is an AI-powered software designed to help radiologists detect lung nodules and masses by analysing the patient’s chest X-rays.

The AI-powered software is designed using advanced machine learning techniques and was developed it using curated training data from across the world.

According to the medical device company, VisiRad XR provides a turnkey solution that is compatible with the current radiology workflow.

The software returns images with AI-detected lesions within the radiologists’ native viewing environment, and requires no additional testing orders, said IMIDEX.

IMIDEX chief medical officer Raj Chopra said: “Radiologists are looking for solutions to help elevate their performance and reduce burnout.

“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.”

Lung nodules serve as an early indication of lung cancer and can be detected in chest X-rays but are often overlooked due to their visual subtlety and rarity in routine care.

IMIDEX said that its VisiRad XR enables clinicians to have a closer look at lung lesions that are often overlooked and enables the identification of future lung cancers.

According to the company, the software provides clinicians second-read for lung nodules and masses in chest X-rays.

IMIDEX CEO Richard Vlasimsky said: “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.

“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.”

IMIDEX has conducted two clinical studies on VisiRad XR, a standalone study and a multi-centre clinical validation study, which supported its 510(k) submission with the US FDA.

In the standalone study, VisiRad XR detected lung nodules and masses in more than 11,000 patient images, at an 83% sensitivity with a fixed false positives per image rate and.

The multi-reader, multi-case clinical validation study evaluated the VisiRad XRm, using six hundred images and twenty-four radiologists from across the country.

VisiRad XR showed statistically significant improvement in each reader’s ability to detect pulmonary nodules and masses, and increased sensitivity across all readers.

University of Colorado professor of medical oncology Paul Bunn said: “Currently, only 20% of lung cancers are detected in the early stages and only 4% of patients at high-risk for lung cancer are routinely screened.

“Increasing our detection of existing lung nodules is key to identifying it early, when the patient’s likelihood of survival is markedly higher.”