Monarch Endoscope Gains FDA 510(k) Clearance for Urology

Ethicon subsidiary Auris Health’s Monarch robotic device has received 510(k) clearance from the FDA for use in endo-urological procedures.

The flexible robotic device, which allows urologists to reach and clearly visualize areas within the kidney, can now be used in treating kidney stones.

The new clearance makes Monarch the first multispecialty, flexible robotic device for use in both bronchoscopy and urology procedures, the company said.

Ethicon expects to launch a first-in-human clinical study later this year for Monarch’s endo-urologic application.