At 9:23 AM ET, the FDA Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee voted 10-0, 6-4, and 7-2 (with one abstention) to determine that Galleri has reasonable safety and effectiveness, and that its clinical benefits outweigh the risks. The product uses AI to identify methylation patterns released by tumors in the blood, allowing for the screening of over 50 types of cancer with a single blood draw, achieving a specificity of 99.85%. Guggenheim analysts stated that this move "virtually eliminated risk," significantly boosting market confidence.