Ultrasound Device Offers Non-Invasive Treatment for Kidney Stones

The U.S. Food and Drug Administration has granted 510(k) clearance to SonoMotion’s Break Wave lithotripsy device, which fragments stones non-invasively with focused ultrasound and requires no anesthesia. Break Wave uses low‑pressure focused ultrasound under real‑time ultrasound guidance to create standing stress waves inside the stone, fragmenting calculi in the kidney or ureter while patients remain fully awake. 

"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, MD, 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 510(k) clearance advances SonoMotion’s anesthesia-free platform, which also includes Stone Clear, a device designed to aid removal of residual fragments following lithotripsy and cleared through the FDA’s de novo pathway in October 2024. Together, the two devices offer a noninvasive, anesthesia-free treatment approach, with Break Wave fragmenting kidney stones and Stone Clear facilitating post-lithotripsy fragment clearance.

"Receiving FDA clearance is a pivotal milestone for our company and, more importantly, for patients seeking better options for kidney stone treatment," said Oren Levy, PhD, Co-Founder and Chief Executive Officer of SonoMotion. "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."

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