FDA Clears Auris Health Robotic Surgery Device

FDA has cleared an Auris Health (Ethicon subsidiary) 510(k) for its Monarch surgery platform’s expanded use for endourological procedures. The clearance makes Monarch the first multispecialty, flexible robotic device for use in both bronchoscopy and urology, Auris says, adding that it is designed to enable urologists to reach and visualize areas within the kidney with “precision and control.”

The device provides one platform that supports both ureteroscopic and percutaneous nephrolithotomy (PCNL) procedures, Auris says. Ureteroscopic procedures are the most common surgical kidney stone procedures globally but become increasingly challenging as stone size increases. “PCNL procedures have demonstrated superior stone clearance for patients with larger kidney stones, yet they represent only 7-8% of stone procedures conducted in the U.S. today,” it says.