Piccolo Medical Receives FDA Clearance for Catheter-Positioning System

Piccolo Medical’s SmartPICC system, a device that helps users navigate peripherally inserted central catheters (PICCs) to the heart’s entryway, has received FDA 510(k) clearance.

The system assists in the positioning of PICCs without the need for X-ray or fluoroscopy to confirm the catheters are placed correctly. It provides real-time tip-location information by using the patient’s cardiac electrical activity and a sensing technology that provides blood-flow information to the caregiver.

The device fits on a wire approximately four to five times the diameter of a human hair that can be easily threaded inside a PICC catheter, the company said.