The purpose of this study was to establish the feasibility of noninvasive treatment of small renal tumors with high-intensity focused ultrasound (HIFU). A 1.69-MHz extracorporeal HIFU transducer of 150-mm focal length was used. In vitro experiments with excised porcine kidneys allowed determination of suitable exposure parameters to be tested in vivo. For short exposure times (< 2 seconds), the minimum energy required to produce acute thermal damage was 500 +/- 100 Wcm-2 per second. Porcine kidneys (N = 18) were treated in vivo at a depth of 40 mm from the skin surface, with acute damage detected in 13. Damage was macroscopically and histologically discrete and confined to the target area within the kidney. Skin induration was observed after treatment in nine cases, and there was one skin burn. Transducer developments to prevent this morbidity and to improve energy deposition within the target are discussed.