Obvius Robotics Completes 1st U.S. Cases with Handheld Robotic System

Obvius Robotics has successfully completed the first cases using its Certa access system with patients in its premarket clinical study in the U.S.

The Certa access system is a handheld robotic platform for image-guided procedures that require precise needle access to anatomical structures. The U.S. Food and Drug Administration (FDA) granted breakthrough status for the device last year, and it’s first being targeted for vascular access procedures.

The system combines ultrasound guidance with robotic needle placement. Its proprietary needle vibration technology reduces soft tissue movement and deformation during insertion, offering the possibility of unmatched precision to pre-selected target tissue.

The first clinical cases were performed at the Texas Medical Center at Baylor St. Luke’s Medical Center and at Northwell Health in New York.

“Our critical care team recently performed its first central venous catheterization procedure successfully with CERTA,” said Dr. Mangala Narasimhan, Director of Critical Care Medicine at Northwell Health. “This is a procedure that today is very manual and requires a highly skilled operator, and CERTA automates precise needle placement in a way that can democratize care.”

After the clinical study is completed, the company said it plans to submit Certa to the FDA by the end of the year. Approval in the U.S. is anticipated for 2026.

“There are over 100 million vascular access procedures performed each year around the world,” said Dave Herrmann, President and CEO of Obvius Robotics. “These procedures require significant expertise and still have high complication rates. We believe CERTA can solve both of these challenges, by offering expert-level precision for any operator, regardless of their experience, at the push of a button.”