Obvius Robotics, a vascular access-focused medical device firm, has received the US Food and Drug Administration (FDA) breakthrough device designation for its CERTA Access System for central venous catheterisation (CVC).
The CERTA Access System is a hand-held, image-guided device that allows clinicians to target anatomical structures. It enables access to these structures with a single button press, using a proprietary targeting system and needle assembly.
The platform technology combines robotics and imaging to enhance the accuracy, safety, and consistency of accessing targeted anatomy.
The system’s initial clinical application focuses on CVC, or central venous catheter placement, which is a high-volume procedure.
This procedure involves accessing one of the major veins such as the internal jugular, subclavian, or femoral to place a multi-lumen catheter.
The catheter is used for rapid blood volume replacement, the administration of emergency medications and analgesics, and haemodynamic monitoring.
According to South Florida-based Obvius Robotics, CERTA can assist clinicians of all experience levels in achieving safe and effective vascular access during these procedures.
In June 2023, the medical device company announced the completion of the first human case using the CERTA system.
Obvius Robotics CEO and president Russell Seiber said: “The goal of Obvius Robotics is to become the new standard of care for CVC access.
“We are excited that the FDA has recognised the potential of the CERTA Access System to be a breakthrough for patients and clinicians.
“We believe this technology could improve care critical care settings by democratising vascular access procedures.”
The CERTA Access System is not yet approved for clinical use. Obvius Robotics is now preparing its submission to the FDA for market clearance, utilising the breakthrough devices programme to expedite the process.
Breakthrough status speeds up the review of new technologies that offer better treatment or diagnosis for serious or debilitating conditions.
To qualify, a device must show it provides a more effective solution than current standards.
The programme aims to give patients quicker access to these devices by accelerating their development and review.
In June, Obvius Robotics relocated to a new development and operations facility to prepare for regulatory clearance and commercialisation.
