The U.S. Food and Drug Administration (FDA) granted SonoMotion, a venture-backed medical device business creating non-invasive kidney stone treatments, 510(k) approval for its Break Wave lithotripsy device. By generating standing stress waves inside kidney stones under real-time ultrasound imaging guidance, Break Wave employs low-pressure focused ultrasound to break up kidney stones. Because the operation is entirely non-invasive and doesn’t require anesthesia, patients may drive themselves to and from it as well as eat and drink beforehand.
“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,” stated 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.”
SonoMotion is creating and marketing a kidney stone therapy platform that includes many devices, such as Stone Clear™ and Break Wave. When combined, the two tools offer a non-invasive, anesthesia-free therapeutic approach: Break Wave breaks up the stone, and Stone Clear aids in removing any remaining pieces from the kidney after lithotripsy. In October 2024, Stone Clear received FDA 510(k) de novo approval.
“Receiving FDA clearance is a pivotal milestone for our company and, more importantly, for patients seeking better options for kidney stone treatment,” stated 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.”
The SonoMotion platform, which includes Stone Clear and Break Wave, will be on display at exhibit #1508 at the American Urological Association (AUA) convention in Washington, DC, on May 15–18, 2026.
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