SonoMotion Gains FDA Clearance for Break Wave Device to Treat Kidney Stones

SonoMotion gains FDA clearance for Break Wave device to treat kidney stones

SonoMotion has received the US Food and Drug Administration (FDA) 510(k) clearance for its Break Wave non-invasive kidney stone treatment device.The post SonoMotion gains FDA clearance for Break Wave device to treat kidney stones appeared first on Medical Device Network.

FDA grants 510(k) clearance to Break Wave lithotripsy device for kidney stones

The safety and efficacy of the Break Wave device was assessed in the pivotal SOUND trial.

SonoMotion announces US FDA clearance for its Break Wave lithotripsy device

SonoMotion’s Break Wave lithotripsy device 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 pr…