The company also said that a pivotal trial of its Break Wave lithotripsy system met its co-primary efficacy and safety endpoints.
San Mateo, California–based SonoMotion earned FDA clearance for the lithotripsy platform at the start of this year. The company now says that it received FDA 510(k) clearance for the next-generation Break Wave device to kick off this month. Its newly cleared version features therapy probes with a 31% smaller footprint and significantly lighter weight.
Break Wave uses low-pressure focused ultrasound to fragment kidney stones. It creates standing stress waves within the stone under real-time ultrasound image guidance. The completely non-invasive procedure requires no anesthesia or sedation, allowing patients to drive themselves to and from the procedure and eat and drink prior to the procedure.
SonoMotion plans to kick off commercialization for the latest Break Wave system in the second half of 2026.
Meanwhile, the S.O.U.N.D clinical trial evaluated the safety and effectiveness of the Break Wave system for the fragmentation of stones in the kidney or ureter. Dr. Ben Chew will present the pivotal trial results, which met their endpoints, this weekend at the 2026 AUA meeting in Washington, D.C.
“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, co-founder and CEO of SonoMotion. “We are proud of the team for continuously improving the technology, and are delighted to offer a truly non-invasive, anesthesia-free treatment that patients need and deserve.”
