EDAP TMS of Lyon, France received FDA 510(k) clearance for its Sonolith i-move mobile lithotripter. The modular device uses an infrared stereo-vision system in combination with ultrasound to help localize and attack kidney stones.
The i-move received European approval last year.
Features from the product page:
Exclusive VisioTrack system for unique stone localization and follow-up during treatment
Infrared Stereo Vision Technology
Hand-held Ultrasound probe for easy access to all stones
Automatic localization
Smart Ultrasound image display on touch screen interface
Real-time tracking of the stone during treatmentSonolith® i-move: a versatile modular lithotripter adapted to all patients
Extended penetration depth up to 180mm for obese patients
Increased patient comfort with the 250mm treatment generator
Designed for endo-urology proceduresState-of-the-art fragmentation technology: Electroconductivity
EDAP TMS and Inserm patented technology
Proven fragmentation efficacy and fineness
Consistent efficiency over time with the patented Automatic Pressure RegulatorSmart investment
Many configurations available to adapt to all needs
Compatible with most X-ray C-arms and Ultrasound scanners available
Press release: EDAP Gains U.S. FDA 510(k) Lithotripter Clearance
Product page: Sonolith i-move