Piccolo Medical Wins FDA Nod for 2nd-Gen SmartPICC System

Piccolo Medical has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its next-gen SmartPICC Stylet and PM2+ system.

SmartPICC offers real-time, accurate bedside catheter tip confirmation for peripherally inserted central catheters (PICCs) by using the patient’s cardiac electrical activity. The technique removes the need for confirmatory chest X-rays to streamline the PICC confirmation procedure and reduce potential care delays.

The first generation of the technology won an FDA nod in September 2024.

The SmartPICC Stylet leverages the company’s proprietary ionic dilution tech for PICC navigation. The feature provides real-time guidance during catheter insertion, which allows for immediate detection of improper advancements through the vasculature.

Piccolo Medical CEO Augustus Shanahan cited U.S. PICC procedural evolution, with catheter navigation systems becoming the undeniable standard of care.

“However, the widespread adoption of these systems has often come with a significant financial burden on our healthcare system,” Shanahan told the press. “We are incredibly proud to introduce a comprehensive vascular access solution to the market that not only prioritizes patient safety and positive outcomes but also empowers hospitals to realize the true economic value of bedside PICC confirmation.”

The company partnered with Spectrum Vascular as its exclusive North American SmartPICC system distributor. Spectrum Vascular provides vascular access and medication management products to hospitals across the country.

“At Spectrum Vascular, we are committed to always delivering leading vascular access solutions that improve outcomes and empower caregivers,” said Ken Miller, CEO of Spectrum Vascular. “By integrating Piccolo’s SmartPICC navigation technology into our offering, we’re helping clinicians achieve greater accuracy and efficiency at the bedside—reducing complications and improving care. It’s one more way we’re working toward a world with fewer complications and better patient outcomes.”