Obvius Robotics announced that it successfully completed the first cases with its Certa handheld robotic platform in the U.S.
The cases came as part of a premarket clinical study for the Certa access system. Fort Lauderdale, Florida-based Obvius designed the platform for image-guided procedures that require precise needle access to anatomical structures. The system holds FDA breakthrough device designation with an initial target for vascular access procedures.
Certa combines ultrasound guidance with robotic needle placement. Its proprietary needle vibration technology reduces the movement and deformation of soft tissue during insertion. The company says this offers the potential for unmatched precision to the pre-selected target tissue.
Obvius Robotics said the first cases took place at the Texas Medical Center at Baylor St. Luke’s Medical Center and at Northwell Health in New York.
Upon completion of the clinical study, the company plans to submit Certa to the FDA by the end of 2025. It anticipates approval to come in 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.”
