SonoMotion, a venture-backed medical device company developing non-invasive solutions for kidney stones, announced today that it received US Food and Drug Administration (FDA) 510(k) 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 anaesthesia, allowing patients to drive themselves to and from the procedure and eat and drink prior to the procedure.
“Break Wave provides a new option for the safe and effective treatment of kidney stones that can be performed in nearly any healthcare setting and does not require a ureteral stent,” said Helena Chang (Kaiser Permanente, Santa Clara, USA). “Patients with symptomatic obstructing ureteral stones can move immediately to treatment, saving weeks of pain and discomfort trying to pass a stone. Additionally, patients with asymptomatic kidney stones have an option to treat stones before they cause a painful event.”
SonoMotion is developing and commercialising a kidney stone treatment platform with several devices, including Break Wave and Stone Clear. 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.
“Receiving FDA clearance is a pivotal milestone for our company and, more importantly, for patients seeking better options for kidney stone treatment,” said Oren Levy, co-founder and chief executive officer of SonoMotion. “This 510(k) clearance represents a significant step toward commercialisation, and we look forward to scaling manufacturing and making our non-invasive, anaesthesia-free solutions available to patients and providers across the urology community.”
