FDA grants 510(k) clearance to Break Wave lithotripsy device for kidney stones

The FDA has granted 510(k) clearance to the Break Wave lithotripsy device for the treatment of patients with kidney stones, SonoMotion announced in a news release.¹

According to the company, the device “uses low pressure-focused ultrasound to fragment kidney stones by creating standing stress waves within the stone under real-time ultrasound image guidance.” The procedure is non-invasive and requires no 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," said Helena Chang, MD, a urologist at Kaiser Permanente, Santa Clara, California, in the news release.¹ "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 safety and efficacy of the Break Wave device was assessed in the pivotal SOUND trial (NCT05701098). In total, the prospective, open-label study enrolled 64 patients with upper urinary tract stones across clinical trial sites in the US and Canada. All patients in the study underwent the Break Wave procedure.

The Break Wave lithotripsy device can work in tandem with SonoMotion’s Stone Clear device, which was granted FDA 510(k) de novo clearance in October 2024.² During the lithotripsy procedure, Break Wave can be used to fragment the stone, and Stone Clear can help clear the kidney of residual fragments post-procedure.

"Receiving FDA clearance is a pivotal milestone for our company and, more importantly, for patients seeking better options for kidney stone treatment," concluded Oren Levy, PhD, co-founder and CEO of SonoMotion, in the news release.¹ "This 510(k) clearance represents a significant step toward commercialization, and we look forward to scaling manufacturing and making our non-invasive, anesthesia-free solutions available to patients and providers across the urology community. We are deeply grateful to the patients who participated in our studies, as well as the support from clinicians, investors, NASA, and the NIH."

REFERENCES

1. SONOMOTION ANNOUNCES FDA CLEARANCE FOR ITS BREAK WAVE™ LITHOTRIPSY DEVICE FOR TREATMENT OF KIDNEY STONES. News release. SonoMotion, Inc. January 21, 2026. Accessed January 21, 2026. https://www.prnewswire.com/news-releases/sonomotion-announces-fda-clearance-for-its-break-wave-lithotripsy-device-for-treatment-of-kidney-stones-302666229.html

2. Sonomotion announces FDA de novo clearance for its Stone Clear device. News release. SonoMotion, Inc. November 13, 2024. Accessed January 21, 2026. https://www.prnewswire.com/news-releases/sonomotion-announces-fda-de-novo-clearance-for-its-stone-clear-device-302303764.html