FDA OKs Piccolo Medical’s Catheter Guidance Tech

Piccolo Medical has earned U.S. Food and Drug Administration (FDA) clearance for its PM2 system with ECGuide connector, a novel catheter guidance technology.
 
ECGuide tech allows real-time determination of catheter tip position by using cardiac electrical activity (ECG). It’s approved as a chest X-ray alternative to confirm correct catheter placement.
 
Catheter guidance systems are routinely used for peripherally inserted central catheter (PICC) procedures but their adoption for central venous catheter (CVC) procedures in the U.S. has been limited, the San Francisco-based company said.
 
“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.”
 
This technology broadens Piccolo’s portfolio of products to reduce complications related to central venous catheter insertion, a procedure that impacts the lives of more than eight million patients per year.
 
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.