Piccolo Medical, Inc. Gains FDA Clearance for ECGuide? Catheter Navigation System
17 September 2024
Piccolo Medical, Inc. (Piccolo) has received FDA clearance to market its PM2™ System with ECGuide™ Connector.
This new catheter guidance technology expands Piccolo's portfolio of products designed to reduce complications from central venous catheter insertions, a procedure performed on over 8 million patients annually.
The ECGuide™ technology enables real-time catheter tip positioning by using the patient’s cardiac electrical activity (ECG), providing an alternative to chest X-ray for confirming proper catheter placement.
Although catheter guidance systems are routinely used for Peripherally Inserted Central Catheter (PICC) procedures, their adoption for Central Venous Catheter (CVC) procedures in the U.S. has been limited.
Despite the availability of guidance systems, many catheters continue to be inserted without guidance, leading to unnecessary risks and additional hospital costs.
The introduction of ECGuide™ aims to address these issues by improving the accuracy of catheter placements and reducing associated costs, with the goal of eliminating malpositioning.
Source: prnewswire.com