FDA Clears Emerging Ultrasound-Based Procedure for Kidney Stones

The Food and Drug Administration (FDA) has issued 510(k) clearance for the ultrasound-based Break Wave lithotripsy device, which may provide a more viable treatment option for people with kidney stones.¹

Noting that kidney stones affect one out 10 people in the United States, SonoMotion, the developer of the Break Wave lithotripsy device, said the modality enables clinicians to combine real-time ultrasound guidance with low pressure ultrasound treatment to fragment kidney stones.

SonoMotion emphasized that the Break Wave lithotripsy procedure is non-invasive and does not require anesthesia.

"Break Wave provides a new option for the safe and effective treatment of kidney stones that can be performed in nearly any health-care setting and does not require a ureteral stent," noted Helena Chang, M.D,, who is affiliated with Kaiser Permanente. "Patients with symptomatic obstructing ureteral stones can move immediately to treatment, saving weeks of pain and discomfort trying to pass a stone. Additionally, patients with asymptomatic kidney stones have an option to treat stones before they cause a painful event."

The company noted that one can combine the Break Wave ultrasound treatment with subsequent use of the Stone Clear system (SonoMotion) for clearing out residual kidney stone fragments from the kidney. A 2024 study of the Stone Clear device, which received FDA De Novo clearance in November 2024, revealed that the system facilitated a 70 percent reduced risk of kidney stone relapse.^2,3

References

1. SonoMotion. SonoMotion announces FDA clearance for its Break Wave lithotripsy device for treatment of kidney stones. BioSpace. Available at: https://www.biospace.com/press-releases/sonomotion-announces-fda-clearance-for-its-break-wave-lithotripsy-device-for-treatment-of-kidney-stones . Published January 22, 2026. Accessed January 22, 2026.
2. Hall J. Ultrasound device garners FDA De Novo nod for kidney stone clearance. Diagnostic Imaging. 2025. Available at: https://www.diagnosticimaging.com/view/ultrasound-device-fda-de-novo-kidney-stone-clearance . Published November 14, 2024. Accessed January 22, 2026.
3. Sorenson MD, Dunmire B, Thiel J, et al. Randomized controlled trial of ultrasonic propulsion-facilitated clearance of residual kidney stone fragments vs observation. J Urol. 2024;212(6):811-820.