Piccolo Medical, Inc. Receives FDA Clearance for ECGuide™ Catheter Guidance Technology
SAN FRANCISCO, Sept. 16, 2024 (PRNewswire) -- Piccolo Medical, Inc. (Piccolo) today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its innovative catheter guidance technology, the PM2™ System with ECGuide™ Connector. This technology expands Piccolo's portfolio of products designed to reduce complications associated with central venous catheter insertion, a procedure affecting the lives of over 8 million patients annually.
The ECGuide™ technology enables real-time determination of catheter tip position by utilizing the patient's cardiac electrical activity (ECG). It is approved as an alternative to chest X-ray for confirming proper catheter placement. While 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.
"Millions of catheters are still being inserted without guidance every year," said Augustus Shanahan, CEO of Piccolo Medical. "The evidence is clear: blind insertions pose unnecessary risks to patients and incur additional costs for hospitals. With the launch of ECGuide™, we aim to overcome barriers related to cost and complexity, ultimately driving the industry towards a goal of zero malpositioning."
About Piccolo Medical:
Piccolo Medical Inc. is a start-up medical device company located in San Francisco, CA. Piccolo was spun out of the Theranova medical device incubator and has been funded by private investors as well as prestigious grant awards from the National Institute of Health's National Institute of Aging. Piccolo received 510(k) clearance for the SmartPICC® System in 2021.
Contact Info:
Email: info@piccolomedical.com
Web: http://www.piccolomedical.com/
