IMIDEX Receives FDA 510(k) Approval for VisiRad™ XR: Pioneering AI Device Enhancing Detection of Lung Nodules in Chest X-Rays

Friday, August 18, 2023

IMIDEX, an industry leader in AI-driven solutions for tackling lung cancer, proudly announces the FDA's clearance for its flagship innovation, VisiRad XR. This revolutionary software harnesses artificial intelligence to meticulously analyze chest X-rays, precisely identifying potential lung nodules and masses. Developed using state-of-the-art machine learning techniques and a meticulously curated global training dataset, VisiRad XR provides healthcare practitioners with an unprecedented tool to uncover subtle lung anomalies that might otherwise go unnoticed. This capability could play a pivotal role in the early detection of impending lung cancers, both within outpatient settings and emergency departments.

In a time marked by rising workloads and a shortage of staff, tools like VisiRad XR are invaluable, enhancing patient care while empowering radiologists to perform at their best. The software seamlessly integrates into the existing radiology workflow, promptly directing images depicting AI-detected anomalies to radiologists within their familiar viewing environment. This integration ensures that VisiRad XR's findings are presented alongside the primary image for interpretation. Without the need for supplementary testing orders, VisiRad XR strives to elevate the rate of detecting lung nodules and masses as part of standard patient care protocols.

Lung cancer claims over 127,000 lives annually in the United States, with nearly half of the cases identified at advanced stages, where survival rates are dismally low. While CT scans are the gold standard for identifying cancerous lung lesions, patient adherence to screening recommendations remains a challenge. In contrast, chest X-rays are a ubiquitous part of standard care, far more common than the guideline-recommended low-dose CT scans. However, lung nodules, early indicators of lung cancer, are often visually subtle and easily overlooked in routine evaluations. This is where VisiRad XR steps in, offering clinicians a "second read" to carefully examine these subtle indicators within chest X-rays.

IMIDEX conducted two comprehensive studies on VisiRad XR, forming the cornerstone of their FDA 510(k) submission. The standalone study, a retrospective analysis of over 11,000 patient images, showcased VisiRad XR's ability to detect lung nodules and masses with a sensitivity rate of 83%, maintaining a Maintaining a consistent false positive rate per image and a steady device operating threshold. Given that chest X-rays are the most common radiological procedure worldwide, the potential impact of VisiRad XR is substantial.



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