“Receiving FDA clearance is a pivotal milestone for our company and, more importantly, for patients seeking better options for kidney stone treatment,” Oren Levy, San Mateo, California–based SonoMotion’s co-founder and CEO, said in a news release yesterday.

“This 510(k) clearance represents a significant step toward commercialization, and we look forward to scaling manufacturing and making our non-invasive, anesthesia-free solutions available to patients and providers across the urology community. We are deeply grateful to the patients who participated in our studies, as well as the support from clinicians, investors, NASA, and the NIH.”