SonoMotion receives FDA approval for its Break Wave gadget to deal with kidney stones

The power is situated in Bandar Baru Sri Petaling, a suburb of Kuala Lumpur. Credit score: NMK-Studio/Shutterstock.

SonoMotion has obtained 510(ok) clearance from the U.S. Meals and Drug Administration (FDA) for its Break Wave non-invasive gadget for the remedy of kidney stones.

The system makes use of low-pressure targeted ultrasound to interrupt up kidney stones by producing standing stress waves within the stone, guided by real-time ultrasound.

Uncover B2B advertising that delivers

Mix enterprise intelligence and editorial excellence to succeed in engaged professionals throughout 36 main media platforms.

Extra info

This non-invasive process requires no anesthesia and permits sufferers to reach and depart independently with out dietary restrictions.

SonoMotion is creating a platform for the remedy of kidney stones, which incorporates the Break Wave and Stone Clear gadgets. Break Wave is meant for stone fragmentation and Stone Clear for clearing residual fragments after lithotripsy.

The Break Wave gadget can fragment kidney stones in totally awake sufferers, in any healthcare setting.

Each gadgets provide an anesthesia-free and non-invasive process. Stone Clear obtained a 510(ok) de novo clearance in October 2024.

SonoMotion co-founder and CEO Oren Levy stated: “Receiving FDA approval is a essential milestone for our firm and, extra importantly, for sufferers on the lookout for higher choices for treating kidney stones.

“This 510(ok) clearance represents an vital step towards commercialization and we look ahead to scaling manufacturing and making our non-invasive, anesthesia-free options accessible to sufferers and healthcare suppliers all through the urology group. We’re very grateful to the sufferers who participated in our research, in addition to the help of physicians, buyers, NASA and the NIH.”

The SonoMotion platform can be on show in sales space 1508 on the 2026 American Urological Affiliation assembly, happening Could 15-18 in Washington, DC.

In November 2024, SonoMotion obtained de novo approval from the FDA for its Stone Clear gadget.