AZmed's AI Tool AZchest Gains Two New FDA Clearances

AZmed has received two new U.S. Food and Drug Administration (FDA) clearances for its AI tool AZchest, announced in a press release. These clearances enhance the tool's capabilities in assisting radiologists with the interpretation and detection of chest X-rays, specifically for lung nodules, and in triaging pneumothorax and pleural effusion.

A standalone study demonstrated AZchest's high sensitivity in detecting lung nodules at 88.47%, with a specificity of 82.94%. When used by experienced radiologists in a controlled trial, the tool increased sensitivity by 10%, reaching 89.35%, and improved the area under the curve (AUC) by 5%. For pneumothorax and pleural effusion, the algorithm showed a sensitivity of 93.79% and 91.34%, respectively, with AUCs of 98.57% and 98.30%.

These advancements position AZchest as one of the most effective AI tools available in the U.S., offering significant diagnostic advantages in clinical practice. AZmed's products are now used in over 2,500 centers across 55 countries, and with AZchest's FDA clearance, U.S. healthcare providers can access this proven solution.