SonoMotion, a venture-backed medical device company developing non-invasive solutions for kidney stones, said it has received FDA clearance for its Break Wave lithotripsy device.
Break Wave uses low pressure-focused ultrasound to fragment kidney stones by creating standing stress waves within the stone under real-time ultrasound image guidance. The procedure is completely non-invasive and requires no anesthesia, allowing patients to drive themselves to and from the procedure and eat and drink prior to the procedure.
SonoMotion is developing and commercializing a kidney stone treatment platform with several devices, including Break Wave and Stone Clear. Together, the two devices provide an anesthesia-free and non-invasive treatment pathway: Break Wave fragments the stone, while Stone Clear helps clear the kidney of residual fragments post-lithotripsy. Stone Clear was granted FDA 510(k) de novo clearance in October 2024.
