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# Piccolo Medical SmartPICC System Cleared
- URL: https://www.fdaweb.com/piccolo-medical-smartpicc-system-cleared/
- Published: 2021-02-22T12:00:00.000Z
- Updated: 2026-09-14T16:47:45.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148719

FDA has cleared a Piccolo Medical 510(k) for its SmartPICC System that is intended to give healthcare providers the ability to navigate peripherally inserted central catheters (PICCs) to the entryway of the heart without relying on x-ray or fluoroscopy confirmation of correct catheter placement. The company says that traditional PICCs that are placed at the bedside without guidance systems result in optimal tip position in about 34% of patients, increasing risks for complications; 19% require repositioning adding cost and delaying care.

Piccolo says the device provides real-time catheter tip location information using both the patient’s cardiac electrical activity and a proprietary sensing technology called ionic dilution, which provides real-time qualitative blood flow information to the caregiver to aid in catheter navigation. “The dual sensor technology fits on a wire approximately four to five times the diameter of a human hair which can be easily threaded inside a PICC catheter,” it says.