The key to improving cancer outcomes for a patient lies in its early detection and this is particularly crucial for lung cancer. Unfortunately, as of now, 49% of lung cancer diagnoses occur at Stage IV, a critical stage where cancer has already spread to other organs, making the prognosis bleak. The 5-year survival rate at this stage is a mere 10%. Lung cancer's generally asymptomatic nature in its early stages often leads to late detection, usually when a chest X-ray or CT is performed for an unrelated reason owing to their visual subtlety and rarity in routine care, coupled with the increasingly intense workloads of radiologists. Now, a groundbreaking AI-powered medical device employs sophisticated computer vision technology to identify these lung nodules and masses in chest X-rays, aiding clinicians in early lung cancer detection and enabling hospitals to treat cancer patients sooner.

IMIDEX’s (Denver, CO, USA) flagship product, VisiRad XR, utilizes AI to analyze chest X-rays and highlight potential lung nodules and masses. The software which uses cutting-edge machine learning techniques was developed using curated global training data. It allows clinicians to focus on lung lesions that are commonly overlooked and might facilitate the early identification of lung cancer in outpatient and emergency department settings. Moreover, VisiRad XR seamlessly integrates into existing radiology workflows by routing images with AI-identified lesions back to the radiologists, who can then interpret the results right behind the primary image. VisiRad XR aims to increase the detection of lung nodules and masses in patients undergoing routine care without the need for additional testing orders.

IMIDEX put VisiRad XR through two large-scale studies: a standalone performance study and a multi-center clinical validation study. The standalone study included over 11,000 patient images, where VisiRad XR demonstrated 83% sensitivity in detecting lung nodules and masses. This could translate to identifying an additional 750 lung nodules or masses annually for an average U.S. hospital performing 50,000 chest X-rays. The multi-reader, multi-case clinical validation study, which involved 600 images and 24 radiologists from various backgrounds, showed that VisiRad XR significantly enhanced the ability to detect pulmonary nodules and masses. This was evidenced by a notable improvement in the area under the curve of the receiver operating curve (AUC) and increased sensitivity for all participating radiologists, irrespective of experience level, specialty, or training. Following the submission of these two comprehensive studies, the US FDA has granted 510(k) clearance for VisiRad XR.

“Radiologists are looking for solutions to help elevate their performance and reduce burnout,” said Dr. Raj Chopra, Chief Medical Officer of IMIDEX. “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.”

“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,” added 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.” 

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