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July 16, 2025
Piccolo’s Second-Generation SmartPICC Technology Cleared by FDA
July 16, 2025—Piccolo Medical, Inc. announced it has received FDA 510(k) clearance to market its next-generation SmartPICC stylet and PM2+ system for peripherally inserted central catheter (PICC) placement.
According to the company, the SmartPICC technology provides real-time, accurate bedside catheter tip confirmation for PICCs by leveraging the patient’s cardiac electrical activity. The technique eliminates the need for confirmatory chest X-rays, streamlining the PICC confirmation procedure and reducing potential delays in patient care, noted the company.
Piccolo also stated that the SmartPICC stylet incorporates the company’s ionic dilution technology for PICC navigation to provide real-time guidance during catheter insertion, allowing for immediate detection of improper advancements through the vasculature.
The press release advised that Piccolo Medical partnered with Spectrum Vascular as the exclusive North American distributor of the SmartPICC system as part of its commercial strategy. The distribution agreement was first announced in January 2025.
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