Obvius Robotics Certa access system earns FDA breakthrough nod

Obvius Robotics Inc. this week said that the U.S. Food and Drug Administration has granted breakthrough device designation for its Certa Access System for central venous catheterization, or CVC.

CVC procedures require access to one of the great veins — internal jugular, subclavian, or femoral — to place a multi-lumen catheter for rapid replacement of blood volume, administration of emergency medicines and analgesics, and hemodynamic monitoring.

Complication rates can range from 4% to 11%, noted Obvius Robotics.