NDR Medical Technology Receives US FDA 510(k) Clearance for ANT-X
Wednesday, June 28, 2023
NDR Medical Technology announced that the ANT-X device has received FDA 510(k) clearance from the U.S. Food and Drug Administration.
ANT-X is an interventional robot that utilises C-arm fluoroscopy to assist clinicians in achieving precise and efficient percutaneous needle placement. With ANT-X, urologists and other healthcare professionals can now approach percutaneous needle placement with greater confidence and accuracy.
This clearance positions ANT-X as the world's first automated robotic device designed to assist in needle positioning and alignment for Percutaneous Nephrolithotomy (PCNL), a procedure used for removing kidney stones.
Approximately about 10 percent of the US population are suffering with kidney stones in their lifetime, and effective treatment is urgently needed. PCNL is considered the preferred treatment for kidney stones due to its higher stone-free rates compared to procedures like ureteroscopy. However, despite its benefits, PCNL only accounts for approximately 7-8 percent of stone procedures performed in the US currently.
The availability of FDA-approved devices like ANT-X has the potential to address this issue by enabling clinicians to safely and effectively perform PCNL procedures on a larger number of patients.