FDA Approves Sonomotion De Novo Clearance for Stone Clear™ Device

SonoMotion, a medical device company focused on non-invasive kidney stone treatments, has received FDA de novo clearance for its Stone Clear™ device. 

This innovative device is the first to utilise external ultrasound pulses to assist in the movement and passage of residual kidney stone fragments following lithotripsy, all without the need for surgery or anaesthesia.

Patients with residual fragments after lithotripsy often face higher risks of complications, emergency visits, or additional procedures. 

The Stone Clear™ device offers a reliable, non-invasive alternative, allowing treatment in a clinical setting while patients remain fully conscious.

Designed for use across various healthcare environments, including clinics, emergency departments, and general practices, Stone Clear™ aims to simplify kidney stone management. 

Clinical trials have shown that ultrasound propulsion using this device reduces relapse risks by 70% compared to standard passive observation. 

SonoMotion aims to transform kidney stone care with these technologies, offering patients alternatives that avoid anaesthesia, reduce surgical delays, and eliminate the need for urinary stents. 

The FDA clearance for Stone Clear™ marks a significant step towards achieving this vision.

Source: https://www.prnewswire.com/news-releases/sonomotion-announces-fda-de-novo-clearance-for-its-stone-clear-device-302303764.html