NDR Medical Technology has made an exciting announcement regarding its ANT-X device. The company has received FDA 510(k) clearance from the U.S. Food and Drug Administration for the ANT-X, making it the world's first automated robotic device for aiding in needle positioning and alignment during Percutaneous Nephrolithotomy (PCNL) procedures. PCNL is a urology procedure used for kidney stone removal. The ANT-X device is designed to empower clinicians by providing image-guided fluoroscopic percutaneous access with enhanced precision and speed.
Kidney stones affect approximately 10 percent of the American population at some point in their lives. PCNL is considered the preferred treatment option for many patients due to its higher stone-free rates compared to other procedures like ureteroscopy. However, PCNL procedures currently account for only about 7-8 percent of stone procedures performed in the United States. The FDA clearance for the ANT-X device will enable clinicians to safely and effectively perform PCNL procedures for a larger number of patients.
In addition to its application in urology, the ANT-X device has shown versatility for other medical indications. In June 2023, NDR Medical Technology successfully conducted its first Neurospine procedure, specifically a discoplasty, in Singapore. The company's vision is to revolutionize the standard of care, and they are actively seeking partners and investors who share their mission of creating innovative solutions that transform the future of healthcare.
The FDA 510(k) approval is a significant milestone for NDR Medical Technology, providing access to the largest healthcare market in the world. The company's progress in expanding the applications of the ANT-X technology demonstrates their commitment to delivering value to customers, partners, and investors.