FDA Clears Break Wave: A New Non-Invasive Approach to Treating Kidney Stones

Published: April 2026 • Written by David Robbins, MD, Board-Certified Urologist, North Miami, FL

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. 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. The technology uses focused ultrasound energy to break stones into smaller fragments that can then be passed naturally. The device can also be used in conjunction with SonoMotion's previously cleared Stone Clear system, which uses ultrasonic propulsion to help move stone fragments through the urinary tract after fragmentation.

The clearance was supported by data from the pivotal SOUND trial, which demonstrated the safety and efficacy of the non-invasive, anesthesia-free ultrasound system in patients with upper urinary tract stones.

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:

• Watchful waiting with medical expulsive therapy — for small stones that may pass on their own with the help of medications
• Extracorporeal shock wave lithotripsy (ESWL) — the existing non-invasive option that uses shock waves to fragment stones, but typically requires sedation or anesthesia
• Ureteroscopy with laser lithotripsy — a minimally invasive procedure in which a small scope is passed through the urinary tract to laser-fragment and remove stones, performed under anesthesia
• Percutaneous nephrolithotomy (PCNL) — a more invasive surgical approach reserved for very large or complex stones

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 stays current with the latest advances in stone management and will continue to offer patients the most effective treatment options based on their individual circumstances.

In the meantime, the best approach to kidney stone management remains a combination of prevention through hydration and dietary modifications and timely treatment by an experienced urologist when stones do develop.

Kidney Stone Treatment in Miami

If you are experiencing kidney stone symptoms or have a history of recurrent stones, Dr. Robbins provides comprehensive kidney and urinary health services at Urological Consultants of Florida. Our practice offers advanced diagnostic imaging, minimally invasive stone removal procedures, and personalized prevention plans.

Call (305) 575-2771 to schedule an appointment at our North Miami office.