SonoMotion has received the US Food and Drug Administration (FDA) 510(k) clearance for its Break Wave non-invasive kidney stone treatment device.
The system employs low-pressure focused ultrasound to break kidney stones by producing standing stress waves inside the stone, guided by real-time ultrasound imaging.
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This non-invasive procedure does not require anaesthesia and allows patients to arrive and leave independently with no dietary restrictions.
SonoMotion is advancing a kidney stone treatment platform that includes the Break Wave and Stone Clear devices. Break Wave is intended for stone fragmentation, and Stone Clear for clearing residual fragments after lithotripsy.
The Break Wave device can fragment kidney stones in patients who are fully awake, in any healthcare setting.
Both devices offer an anaesthesia-free and non-invasive pathway. Stone Clear received 510(k) de novo clearance in October 2024.
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By GlobalDataSonoMotion co-founder and CEO Oren Levy said: “Receiving FDA clearance is a pivotal milestone for our company and, more importantly, for patients seeking better options for kidney stone treatment.
“This 510(k) clearance represents a significant step toward commercialisation, and we look forward to scaling manufacturing and making our non-invasive, anaesthesia-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 will be showcased at booth 1508 during the 2026 American Urological Association meeting taking place on 15-18 May in Washington, DC.
In November 2024, SonoMotion received the FDA de novo clearance for its Stone Clear device.
