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.