FDA Clears Updated SonoMotion Break Wave; Company Says Pivotal Trial Met Endpoints

The US Food and Drug Administration has cleared a next-generation version of SonoMotion's Break Wave, a focused ultrasound device that breaks up kidney and ureteral stones without anesthesia, and the company said its pivotal trial met its co-primary efficacy and safety endpoints, according to a May 14 release distributed by PR Newswire.

The FDA's 510(k) database lists the clearance as K261086, a special 510(k) received on April 1, 2026, with a substantially equivalent decision dated April 29. The company's release gives the clearance date as May 1. The device is classified as an extracorporeal shock-wave lithotripter under product code LNS. The predicate is SonoMotion's own original Break Wave, cleared in January 2026 under K252913.

What changed in the device

According to the clearance letter and 510(k) summary, Break Wave is "intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper and lower ureter)," the same indication as the predicate. The operator scans the abdomen with a coupled imaging probe to find the stone, then triggers therapy with a foot pedal and watches fragmentation in real time. The summary says the device can be used without sedation.

The summary lists four changes: a smaller probe diameter, a fourth therapy probe to improve focal coverage, RFID technology "for pay-for-use licensing," and minor user interface updates. SonoMotion said the new therapy probes have a 31% smaller footprint and are significantly lighter. Testing cited in the summary covers electrical safety, electromagnetic compatibility, lithotripter standards, usability and software validation.

The pivotal trial

The S.O.U.N.D trial is registered as NCT05701098 on ClinicalTrials.gov, which lists it as a completed, non-randomized study that enrolled 64 participants at 10 locations, with primary completion in June 2025. Its primary effectiveness endpoint is the proportion of patients whose target stone is either cleared or reduced to fragments of 4 mm or less on imaging 10 weeks, plus or minus two, after the final procedure. The primary safety endpoint is the occurrence of device- or procedure-related clinically significant hematoma, urinary tract sepsis or serious cardiac arrhythmia through 90 days.

In its May release, SonoMotion said only that the trial met its co-primary endpoints; the release gave no stone-free rates or adverse event figures. The company-reported results will be presented on behalf of the investigators by Ben Chew of the University of British Columbia in a plenary session at the American Urological Association annual meeting in Washington on May 16.

"Meeting our pivotal trial endpoints while receiving FDA clearance for a more compact device puts us in a strong position to bring Break Wave to the millions of patients who suffer from kidney stones each year," said Oren Levy, SonoMotion's co-founder and chief executive. The San Mateo, California, company said commercialization will begin in the second half of 2026.