In January 2026, the FDA granted 510(k) clearance to the Break Wave lithotripsy device, manufactured by SonoMotion, for the treatment of patients with kidney stones.12 This clearance represents an important milestone in the ongoing evolution of kidney stone treatment toward less invasive approaches.
As a urologist who treats kidney stones regularly at our North Miami practice, I want to explain what Break Wave is, how it differs from existing treatments, and what it may mean for patients in the future.
What Is the Break Wave Device?
Break Wave is a non-invasive, anesthesia-free ultrasound-based lithotripsy system designed to fragment kidney stones from outside the body. It uses low-pressure focused ultrasound, aimed under real-time ultrasound imaging, to break stones into smaller fragments that can then be passed naturally.2 The device can also be used in conjunction with SonoMotion’s Stone Clear system, authorized by the FDA in October 2024, which uses ultrasonic propulsion to help move stone fragments through the urinary tract after fragmentation.1
The clearance was supported by data from the pivotal SOUND trial, which studied the safety and efficacy of the non-invasive, anesthesia-free ultrasound system in 64 patients with upper urinary tract stones at sites in the United States and Canada.2
How Does This Compare to Current Kidney Stone Treatments?
Kidney stone treatment depends on the stone’s size, location, and composition. The current standard of care includes:
| Treatment | How it works | Anesthesia |
|---|---|---|
| Watchful waiting with medical expulsive therapy | Small stones may pass on their own with the help of medications. | None |
| Break Wave (new) | Focused ultrasound fragments the stone from outside the body. | None |
| Extracorporeal shock wave lithotripsy (ESWL) | The existing non-invasive option; shock waves fragment the stone. | Typically sedation or anesthesia |
| Ureteroscopy with laser lithotripsy | A small scope passed through the urinary tract to laser-fragment and remove stones. | Anesthesia |
| Percutaneous nephrolithotomy (PCNL) | A more invasive surgical approach reserved for very large or complex stones. | Anesthesia |
Break Wave fits into this landscape as a potentially office-based, anesthesia-free alternative for appropriate candidates. If the technology proves effective in broader clinical use, it could reduce the need for operating room time, anesthesia, and the recovery associated with surgical stone procedures.
What This Means for Patients Right Now
It is important to note that Break Wave is a newly cleared device and is not yet widely available. As the technology becomes more established, its role in clinical practice will become clearer. At Urological Consultants of Florida, Dr. Robbins follows advances in stone management and recommends treatment based on each patient’s stone and circumstances.
Break Wave is a newly cleared device and is not yet widely available.
Dr. David Robbins
In the meantime, kidney stone management remains a combination of prevention through hydration and dietary modifications and timely treatment by a urologist when stones do develop. Our kidney stone prevention diet article explains the diet side.
Kidney Stone Treatment in Miami
If you are experiencing kidney stone symptoms or have a history of recurrent stones, Dr. Robbins provides kidney and urinary health services at Urological Consultants of Florida, including diagnostic imaging, minimally invasive stone removal procedures, and prevention plans.
Call (305) 672-4222 to schedule an appointment at our North Miami office.
Sources
Clearance details checked against the FDA’s device databases in October 2026.
- U.S. Food and Drug Administration. 510(k) K252913: Break Wave (SonoMotion).
- Urology Times. FDA grants 510(k) clearance to Break Wave lithotripsy device for kidney stones.
