SONOMOTION ANNOUNCES FDA DE NOVO CLEARANCE FOR ITS STONE CLEAR™ DEVICE

SAN MATEO, Calif., Nov. 13, 2024 /PRNewswire/ -- SonoMotion, a medical device company developing non-invasive solutions for kidney stones, announced today that the FDA has granted de novo clearance for the Company's Stone Clear™ device for the anesthesia-free treatment of post-lithotripsy kidney stone fragments.

Stone Clear is the first and only device that delivers ultrasound pulses externally to move and facilitate the passage of residual fragments without surgery and in the clinic setting.

“Patients with post-lithotripsy residual fragments are more likely to have complications, emergency department visits, or repeat procedures, yet they have no reliable non-invasive option aside from passive observation,” said James E. Lingeman, MD, Clinical Professor of Urology, Indiana University School of Medicine. “The Stone Clear device provides patients with a non-invasive option to reduce their residual fragment stone burden in the clinic environment while being fully awake.”

The Stone Clear device is part of a platform designed to treat kidney stones without requiring anesthesia and in any health care settings where a patient with a kidney stone may present themselves, including the doctor’s office and emergency departments. Ultrasound propulsion in patients with post-lithotripsy residual fragments reduced the risk of relapse by 70% compared to standard-of-care observation.2 Results from the randomized controlled clinical trial with up to five-year follow-up are published in the December 2024 issue of the Journal of Urology.

Sign up for Blog Updates