SonoMotion's Break Wave™ Device Receives FDA Clearance for Kidney Stone Treatment

SonoMotion's Break Wave™: A New Horizon in Kidney Stone Treatment

In a groundbreaking development, SonoMotion, a medical technology startup based in San Mateo, California, has announced that it has received FDA 510(k) clearance for its innovative Break Wave lithotripsy device. Designed specifically for treating kidney stones, this FDA approval marks a pivotal moment not just for the company, but for patients struggling with one of the most common urological conditions.

Understanding Kidney Stones

Kidney stones are a prevalent health issue, affecting approximately one in ten individuals in the United States. They are not only painful but also a financial burden, leading to an estimated $10 billion in healthcare costs annually. Traditional treatment options often involve invasive procedures, which can include anesthesia and lengthy recovery times. Therefore, there is a critical need for effective, non-invasive solutions in the realm of urology.

What is Break Wave™?

The Break Wave device utilizes low-pressure focused ultrasound to safely fragment kidney stones. Unlike conventional treatments, this technique allows for real-time ultrasound image guidance, ensuring precision in targeting stones without the need for any form of anesthesia. As patients remain fully conscious throughout the procedure, they are empowered to manage their own care experience, including the ability to drive themselves to and from the treatment session.

Dr. Helena Chang, a prominent Urological specialist with Kaiser Permanente, praised the Break Wave device, stating, "This represents a significant advancement in how we approach kidney stone treatment, providing a safe and effective option that can be performed in virtually any healthcare setting without the complications typically associated with ureteral stents." Patients can now swiftly transition from diagnosis to treatment, alleviating weeks of pain by addressing obstructing stones immediately.

Continuing Innovation

SonoMotion has ambitious plans for its kidney stone treatment platform, which includes the Break Wave and an additional device named Stone Clear™. While Break Wave focuses on fragmenting the stones, Stone Clear is designed for clearing residual fragments post-lithotripsy. Notably, Stone Clear received its de novo FDA clearance in October 2024, demonstrating SonoMotion’s commitment to developing a comprehensive and effective treatment strategy for patients experiencing kidney stones.

The co-founder and CEO of SonoMotion, Dr. Oren Levy, expressed immense gratitude for reaching this crucial milestone, stating, "Receiving FDA clearance is not just a win for our company but for all patients seeking improved treatment options for kidney stones. This is a significant step towards commercialization, and we are excited to scale manufacturing and make our non-invasive solutions available to healthcare providers across the urology field."

Future Prospects

The Break Wave technology is expected to be prominently featured at the upcoming 2026 American Urological Association (AUA) meeting, slated for May 15-18 in Washington, DC. This event will present an opportunity for medical professionals to engage with and learn more about the innovative capabilities of the Break Wave device.

As the landscape of kidney stone treatment evolves, the introduction of the Break Wave lithotripsy device by SonoMotion embodies a significant transition towards more patient-centered, less invasive medical interventions. With promising clinical outcomes anticipated, we may be witnessing the dawn of a new era in urological treatment.