SonoMotion Receives FDA Clearance for Break Wave Non-Invasive Kidney Stone Treatment Device
Key Insights
SonoMotion (search) has received FDA 510(k) clearance for its Break Wave (search) device, which uses low-pressure focused ultrasound to fragment kidney stones without requiring anesthesia or dietary restrictions.
The non-invasive system employs standing stress waves guided by real-time ultrasound imaging and can be performed in any healthcare setting with patients fully awake.
Break Wave (search) works alongside Stone Clear (search), which received FDA de novo clearance in October 2024, to provide a complete anesthesia-free treatment pathway for kidney stone management.
SonoMotion (search) has received US Food and Drug Administration (FDA) 510(k) clearance for its Break Wave (search) non-invasive kidney stone treatment device, marking a significant advancement in urological care. 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.
Revolutionary Non-Invasive Approach
The Break Wave (search) device represents a paradigm shift in kidney stone treatment, offering a non-invasive procedure that does not require anesthesia and allows patients to arrive and leave independently with no dietary restrictions. The device can fragment kidney stones in patients who are fully awake, in any healthcare setting.
"Break Wave (search) 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."
Comprehensive Treatment Platform
SonoMotion (search) is advancing a kidney stone treatment platform that includes both the Break Wave (search) and Stone Clear (search) devices. Break Wave is intended for stone fragmentation, while Stone Clear is designed for clearing residual fragments after lithotripsy. Together, the two devices provide an anesthesia-free and non-invasive treatment pathway. Stone Clear received 510(k) de novo clearance in October 2024.
Clinical Impact and Commercialization
"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 (search). "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."
Levy expressed gratitude to the patients who participated in their studies, as well as the support from clinicians, investors, NASA, and the NIH. The SonoMotion (search) platform, including Break Wave (search) and Stone Clear (search), will be featured at booth #1508 during the upcoming 2026 American Urological Association (AUA) meeting, May 15-18 in Washington, DC.
The San Mateo, California-based VC-backed startup is positioning itself as a leader in developing next-generation non-invasive solutions for kidney stone treatment, with the potential to transform patient care in urology practices nationwide.