Break Wave Lithotripsy Cleared by FDA for Anesthesia-Free Kidney Stone Care

Break Wave lithotripsy received FDA 510(k) clearance on January 21, 2026, supported by the pivotal SOUND trial of 64 awake patients. SonoMotion’s device fragments kidney stones with low-pressure focused ultrasound — no anesthesia, no ureteral stent, in any care setting.

April 25, 2026 · 3 min read

The Story at a Glance:

Break Wave lithotripsy gained FDA 510(k) clearance on January 21, 2026, for non-invasive treatment of kidney stones in fully awake patients.
The device uses low-pressure focused ultrasound under real-time ultrasound guidance — no anesthesia and no ureteral stent required.
The pivotal SOUND trial enrolled 64 patients with upper urinary tract stones across U.S. and Canadian sites.
A companion device, Stone Clear (FDA-cleared October 2024), uses ultrasonic propulsion to facilitate post-lithotripsy fragment clearance.

What Happened

Break Wave lithotripsy received FDA 510(k) clearance on January 21, 2026, for the treatment of patients with kidney stones, according to manufacturer SonoMotion, Inc. The device uses low-pressure focused ultrasound to fragment stones by creating standing stress waves inside the stone, guided by real-time ultrasound imaging.

Unlike conventional shock wave lithotripsy (SWL), Break Wave operates at lower pressure amplitudes and higher pulse repetition rates (10–100 Hz versus 1–2 Hz for SWL), which permits the procedure to be performed on fully awake patients without anesthesia or sedation. Patients may eat and drink before treatment and drive themselves to and from the procedure. No ureteral stent is required.

The technology was developed at the University of Washington Applied Physics Laboratory through a long-running NIH program, with NASA funding, and was licensed to SonoMotion. The clearance was supported by the pivotal SOUND trial (NCT05701098), which enrolled 64 patients with upper urinary tract stones at U.S. and Canadian sites.

Why Break Wave Lithotripsy Matters

Break Wave lithotripsy reframes where and how kidney stones are treated. Approximately one in ten Americans are affected by stone disease at some point in their lives, generating roughly 750,000 lithotripsy procedures and around $10 billion in annual costs. Conventional SWL requires anesthesia in a dedicated SWL suite or operating room, while ureteroscopy requires general anesthesia and often a temporary ureteral stent.

Moving fragmentation into the clinic or emergency department on awake patients could collapse the time from presentation to treatment for symptomatic obstructing stones, eliminate stent-related morbidity in selected cases, and shift volume out of the operating room.

Key Numbers

Pivotal data and operational specifications are summarized below.

FDA action: 510(k) clearance, January 21, 2026, for kidney stone fragmentation
Pivotal SOUND trial (NCT05701098, n=64): prospective, single-arm, U.S. and Canadian sites in patients with upper urinary tract stones
First-in-human trial (Chew et al., J Urol October 2024): 44 patients across 5 North American centers; stone fragmentation in 88%; 70% with fragments ≤ 4 mm; 49% completely stone-free on CT at ~70 days; no serious adverse events
Treatment time: typically 10 to 30 minutes per session
Site of care: clinic/office, emergency department, SWL suite, or operating room
Companion device: Stone Clear (FDA 510(k) de novo, October 2024) for ultrasonic-propulsion clearance of residual fragments

What Experts Are Saying

“can be performed in nearly any healthcare setting” — Helena Chang, MD, Kaiser Permanente, on the Break Wave device

Chang added that the procedure does not require a ureteral stent, which removes one of the most patient-burdensome elements of conventional treatment for symptomatic obstructing stones. From the company side, Oren Levy, PhD, co-founder and chief executive officer of SonoMotion, framed the clearance as the prerequisite for scaling manufacturing and broader rollout of anesthesia-free stone therapy across the urology community.

What’s Next for Break Wave Lithotripsy

SonoMotion plans to scale manufacturing and roll out commercial availability across the U.S. urology community, with the platform exhibiting at the 2026 American Urological Association annual meeting in Washington, DC, on May 15–18. Real-world data on stone-free rates, retreatment rates, and clinical workflow integration are anticipated as adoption expands. Insurance coverage and CPT-code pathways for an in-office, non-invasive lithotripsy modality remain a key open question that will shape uptake in private and hospital practice.

Bottom Line

Identify candidates for Break Wave lithotripsy: upper-urinary-tract stones that would otherwise need OR-based SWL or ureteroscopy with stent placement.
Counsel patients on realistic outcomes: ~49% complete clearance at 70 days in pivotal data, with fragmentation in ~88% of cases.
Confirm reimbursement and CPT coding before scheduling — coverage for in-office lithotripsy is still evolving.
Watch for retreatment rates and direct head-to-head comparisons with conventional SWL in post-marketing data.

Sources

SonoMotion, Inc. SonoMotion Announces FDA Clearance for Its Break Wave Lithotripsy Device for Treatment of Kidney Stones. Press release, January 21, 2026. SonoMotion Press Release — Break Wave FDA Clearance
Saylor BP. FDA grants 510(k) clearance to Break Wave lithotripsy device for kidney stones. Urology Times, March 2026. Urology Times — Break Wave FDA Clearance Coverage
Chew BH, Sur RL, Buckley JC, et al. Break Wave Lithotripsy for Urolithiasis: Results of the First-in-Human International Multi-Institutional Clinical Trial. J Urol. 2024;212(4):cover article. Journal of Urology — First-in-Human Break Wave Lithotripsy Trial (Chew et al., 2024)
Harper JD, Cunitz BW, Dunmire B, et al. First In-Human Burst Wave Lithotripsy for Kidney Stone Comminution: Initial Two Case Studies. J Endourol. 2021. Journal of Endourology — First-in-Human BWL Case Studies (Harper et al., 2021)
Hall J. FDA Clears Emerging Ultrasound-Based Procedure for Kidney Stones. Diagnostic Imaging, January 2026. Diagnostic Imaging — Break Wave Coverage