FDA Clears SonoMotion’s Break Wave Lithotripsy Device

SonoMotion has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Break Wave lithotripsy device, a tool that uses low pressure-focused ultrasound to fragment kidney stones by creating standing stress waves within the stone under real-time ultrasound image guidance.

The low pressure-focused ultrasound procedure is completely non-invasive and requires no anesthesia, allowing patients to drive themselves to and from the procedure and eat and drink prior to the procedure.

“Break Wave provides a new option for the safe and effective treatment of kidney stones that can be performed in nearly any healthcare setting and does not require a ureteral stent,” said Helena Chang, M.D., 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.”

SonoMotion is developing and commercializing a kidney stone treatment platform with several devices, including Break Wave and Stone Clear. Both devices provide an anesthesia-free and non-invasive treatment pathway: Break Wave fragments the stone, while Stone Clear helps clear the kidney of residual fragments post-lithotripsy. Stone Clear secured U.S. Food and Drug Administration (FDA) 510(k) de novo clearance in October 2024.

“Receiving FDA clearance is a pivotal milestone for our company and, more importantly, for patients seeking better options for kidney stone treatment,” SonoMotion Co-Founder/CEO Oren Levy, Ph.D., stated. “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.”

The SonoMotion platform, including Break Wave and Stone Clear, will be featured during the 2026 American Urological Association meeting (May 15-18) in Washington, D.C.

SonoMotion, a venture capital-backed medtech startup, is developing next-generation non-invasive solutions for kidney stone treatment. The firm is based in San Mateo, Calif.

Reference
Litwin MS, CS S. NIH Publication No. 12-7865.