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# SonoMotion De Novo for Stone Clear Ultrasound
- URL: https://www.fdaweb.com/sonomotion-de-novo-for-stone-clear-ultrasound/
- Published: 2024-11-14T12:00:00.000Z
- Updated: 2026-09-14T14:47:02.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158191

FDA has granted SonoMotion a de novo marketing authorization for its Stone Clear device for the anesthesia-free treatment of post-lithotripsy kidney stone fragments. The device is designed to deliver ultrasound pulses externally to move and help the passage of residual fragments without surgery, according to the company.

The authorization was based on data showing that ultrasound propulsion in patients with post-lithotripsy residual fragments reduced the risk of relapse by 70% compared to standard-of-care observation, the company says. Results from its randomized controlled clinical trial are published in the December issue of the [Journal of Urology](https://c212.net/c/link/?t=0&l=en&o=4301354-1&h=1378554816&u=https%3A%2F%2Fwww.auajournals.org%2Fdoi%2F10.1097%2FJU.0000000000004186&a=Journal+of+Urology&ref=fdaweb.com).

SonoMotion is currently evaluating its ultrasound product called Break Wave that can operate on the same Stone Clear platform for focused ultrasound to non-invasively fragment kidney stones in the upper urinary tract without anesthesia. That device is currently undergoing clinical trials in the U.S. and Canada.