Review of the safety profile for microfocused ultrasound with visualization

Summary The Safety of Microfocused Ultrasound with Visualization (MFU‐V) has been well established in both controlled clinical studies and in clinical use, showing only mild and transient anticipated side effects and only rare unanticipated adverse events (AEs). This publication discusses the safety profile of MFU‐V based on data from a variety of sources. Reports of side effects and AEs were obtained from published peer‐reviewed medical literature, clinical studies, in‐market use reports (AEs reported to the manufacturer), and retrospective chart reviews of patient treatments. Events that were typical included tenderness, redness, and slight edema. Rare events included bruising, welting, and nerve‐related effects (paresthesia and paresis). Rare incidence of surface thermal effects was seen in some cases where improper technique was used. In all cases where the device was uses properly, the safety events reported tended to be transient, mild in nature, and resolved without sequelae. In general, unexpected and rare AEs could be attributed to incorrect treatment technique or classified as unrelated to MFU‐V treatment. Side effects that do occur are generally mild and transient in nature. MFU‐V consistently allows for safe treatment when correct treatment technique is used.