The US Food and Drug Administration (FDA) has awarded breakthrough device designation for Obvius Robotics’ Certa Access System for central venous catheterisation (CVC).

The hand-held image-guided percutaneous access device aims to standardise and improve the outcomes of these procedures.

Certa is not yet approved for clinical use. Obvius Robotics is actively preparing for its FDA market clearance submission.

Obvius Robotics chief medical officer William Cohn said: “CVC procedures are required for a wide variety of conditions and patients for life-saving care every single day.

“Despite this fact, the procedure still has high complication rates and many health systems lack the expertise to reliably conduct the procedure on critically ill patients in a timely manner. A breakthrough is truly needed to improve care.”

The device makes use of image guidance and precise, targeted needle placement, enabling clinicians to identify target structures such as blood vessels, and rapidly gain access for CVC placement.

Obvius Robotics president and CEO 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.”

In June 2023, Obvius Robotics completed the first in-human study using its CERTA Access System.

The device combines robotics and imaging, allowing clinicians to single-handedly target and access anatomical structures using a targeting system and needle assembly.