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IMIDEX Receives FDA Clearance for AI-Powered Chest X-Ray Evaluation Software program

IMIDEX, a medical expertise firm, has obtained 510(ok) clearance from the US Meals and Drug Administration (FDA) for its new synthetic intelligence (AI)-powered medical machine known as VisiRad XR. The software program has been particularly designed for the evaluation of chest X-rays and the identification of potential lung nodules and much.

Developed utilizing superior machine studying strategies and globally curated coaching knowledge, VisiRad XR permits clinicians to carefully look at lung abnormalities which might be typically neglected. This enhanced examination course of has the potential to help within the early detection of lung cancers in each outpatient and emergency division settings.

With assistance from AI, VisiRad XR sends photographs with detected lesions to radiologists, permitting them to simply view the outcomes alongside the principle picture for interpretation, with out the necessity for extra testing orders. This software program goals to enhance the detection of lung nodules and much throughout routine care, with out including any additional burden on medical professionals or sufferers.

IMIDEX carried out a standalone efficiency research and a multi-center medical validation research on VisiRad XR as a part of its 510(ok) submission to the FDA. Within the retrospective research, utilizing a dataset of over 11,000 affected person photographs, VisiRad XR demonstrated an 83% sensitivity in figuring out lung nodules and much. This accuracy was maintained whereas conserving the speed of false positives per picture constant and utilizing a hard and fast machine working threshold.

IMIDEX’s Chief Medical Officer, Dr. Raj Chopra, acknowledged that instruments like VisiRad XR are important for radiologists who’re searching for methods to reinforce their efficiency and cut back burnout. As medical imaging volumes improve and staffing ranges lower, software program options with AI capabilities can contribute to each improved affected person care and the flexibility of radiologists to apply at their full potential.

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