NDR Medical Technology, an artificial intelligence (AI)-empowered interventional robotics company in Singapore, has on Wednesday announced that its automated robotic
device automated needle targeting system (ANT)-X has been granted FDA 510(k) clearance by the United States Food and Drug Administration (FDA).

This clearance makes ANT-X an automated robotic device to aid in needle positioning and alignment to access the kidney for percutaneous nephrolithotomy (PCNL), a urology procedure for kidney stone removal, NDR Medical Technology said in a statement.

According to the statement, the device is designed to empower clinicians to perform image-guided fluoroscopic percutaneous access with speed and precision.

NDR Medical Technology said that approximately 10 percent of the American population is affected by kidney stones in their lifetime, and there is a pressing need for effective treatment.

It said among treatment options available for patients, PCNL stands out as the preferred treatment of choice for patients, as it tends to see higher stone-free rates compared with procedures such as ureteroscopy.

Despite its benefits, it said PCNL represents only an estimated 7 to 8 percent of stone procedures conducted in the United States today.

With FDA approval secured for the ANT-X, it said clinicians will be able to carry out PCNL procedures safely and effectively for a larger number of patients.

“As urologists, we recognize that achieving percutaneous access to the renal collecting system is a crucial step that significantly impacts the success of kidney stone surgery,” said Dr Kazumi Taguchi, Assistant Professor and head of research of Nephro-urology at Nagoya City University.

“Despite advancements in surgical techniques, we are still faced with the daunting task of performing this procedure, which demands considerable time and effort,” he added.

With the advancement of PCNL techniques such as mini PCNL and ultra-mini PCNL, NDR Medical Technology opined that more patients can be discharged on the same day without the need for stents, tubing, or any remaining stones.

“Recent trends show an increase in the use of PCNL targeting stones up to 2cm, while Mini PCNL has been proven to minimize adverse events. We are confident that the adoption of ANT-X reduces the complexity of such procedures.” said Alan Goh, Chief Executive Officer, NDR Medical Technology.

It is noted that in the United States, current reimbursement codes cover procedures for stone sizes up to 2cm or larger, with new updates to the codes allowing urologists to be incentivized for performing their own access in PCNL procedures.

With ANT-X, NDR Medical Technology said urologists can now confidently perform image-guided access, which was previously challenging without assistance.

Beyond urology procedures, the versatility of ANT-X extends to other indications.

In Singapore, the company successfully conducted its first Neurospine procedure, discoplasty, in June 2023.

Driven by a vision to revolutionize the standard of care, NDR Medical Technology is seeking partners and investors to join in the mission of creating breakthrough solutions that transform the future of healthcare.

“Achieving FDA 510(k) approval gives NDR Medical Technology access to the largest healthcare market in the world, and is a critical step ahead for the company,” said Hsien-Hui Tong, Executive Director – Investments, SGInnovate.

“This milestone is a sign of consistent good traction made by the team as it continues to expand the applications of its technology, and deliver value to its customers, partners and investors,” he added.

Singapore healthtech firm Qritive raises $7.5M led by MassMutual Ventures