Avation Medical, Inc., the innovator in patient-friendly, closed-loop neuromodulation options to treat life-altering medical conditions, today announced that its Vivally System received US Food and Drug Administration (FDA) 510(k) clearance. Vivally is a non-invasive, bladder control therapy device and mobile application to treat patients with the conditions of urinary urgency and urge urinary incontinence (UUI) caused by overactive bladder (OAB) syndrome, without the need for surgery, drugs, or needle-electrodes. The Vivally System is the only closed-loop, non-invasive neuromodulation system for bladder control cleared for sale in the United States. Closed-loop control objectively confirms activation of the tibial nerve and continuously adjusts therapy parameters to ensure optimal output throughout the session. Read more.

Source: PRNewswire, April 11, 2023