SonoMotion Break Wave Lithotripsy Device Meets Pivotal Trial Primary Endpoints
SonoMotion announces that its Break Wave Lithotripsy Device has met its co-primary efficacy and safety endpoints in a pivotal trial. The device, which uses low pressure focused ultrasound for kidney stone fragmentation, is non-invasive and requires no anesthesia. Results will be presented at the 2026 AUA meeting. The company also received FDA clearance for a next-generation device that is smaller and lighter, with commercialization expected in the second half of 2026.
Full trial results to be presented at the American Urological Association (AUA) annual meeting on May 16, 2026 The Break Wave device non-invasively fragments stones in the kidney or ureter on fully awake patients, without anesthesia, and at any site of care – with the potential to become…