The FDA-cleared Stone Clear device uses non-invasive ultrasound pulses to facilitate passage of kidney stone fragments post-lithotripsy. Credit: SofikoS / Shutterstock.

SonoMotion has received the US Food and Drug Administration (FDA) de novo clearance for its Stone Clear device, a non-invasive solution for treating post-lithotripsy kidney stone fragments without anaesthesia.

This device uses external ultrasound pulses to facilitate the passage of residual fragments in a clinical setting.

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Stone Clear is part of a platform designed to treat kidney stones in various healthcare settings, including doctor’s offices and emergency departments.

SonoMotion co-founder and CEO Oren Levy said: “SonoMotion’s goal is to fundamentally change how kidney stones are treated, and securing FDA clearance for Stone Clear is a major milestone towards this goal.

“SonoMotion’s technologies have the potential to be a first-line treatment for kidney stones, offering a solution for patients who want to avoid anaesthesia, minimise wait times for surgery without the need for urinary stenting – a procedure often more painful than the kidney stone itself.”

The device’s ultrasound propulsion technology reduces the risk of relapse in patients by 70% against standard observation.

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These findings are detailed in a randomised controlled clinical trial published in the Journal of Urology December 2024 issue.

Indiana University School of Medicine clinical professor of urology James Lingeman said: “Patients with post-lithotripsy residual fragments are more likely to have complications, emergency department visits, or repeat procedures, yet they have no reliable non-invasive option aside from passive observation.

“The Stone Clear device provides patients with a non-invasive option to reduce their residual fragment stone burden in the clinic environment while being fully awake.”

SonoMotion is also developing Break Wave, another solution that operates on the same platform. It uses focused ultrasound to fragment kidney stones in the upper urinary tract non-invasively.

Break Wave is undergoing clinical trials at present in the US and Canada.