Study summary

An ultrasound device that breaks stones without anesthesia met its goals

Break Wave pivotal trial · Pivotal device trial · Reported May 2026; FDA 510(k) clearance May 2026

What was tested

SonoMotion Break Wave, which uses low-pressure focused ultrasound to fragment kidney stones, in a pivotal trial.

What they found

• The trial met its co-primary endpoints, per the company.
• The next-generation device received FDA clearance.

What it means

Could allow stone treatment in an office setting without sedation. Peer-reviewed data are pending.