Ultrasound Update: Next-Generation Lithotripsy Device Gets FDA Nod

Less than four months after the original Break Wave lithotripsy device received 510(k) clearance from the Food and Drug Administration (FDA) for kidney stone treatment, a newly updated version of the device has received FDA clearance as well.

SonoMotion, the developer of the BreakWave device, said the newly cleared version of the platform offers lighter weight and ultrasound therapy probes that have a 31 percent smaller footprint.

The company noted that pivotal trial results for the BreakWave system — which combines real-time ultrasound guidance with low-pressure ultrasound treatment to fragment kidney stones — will be unveiled at the upcoming American Urological Association (AUA) conference May 15-18, 2026 in Washington, D.C.

"The Break Wave device represents the only anesthesia-free and ionizing radiation-free option to treat kidney stones in a variety of health-care settings, which means it can be delivered to patients where they need it,” noted Ryan Hsi, MD, an associate professor of urology at the University of California. “Since it is non-invasive, it will allow patients to recover quickly and return to their busy lives."