Piccolo Medical, a leading innovator in vascular access technology, announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its next-generation SmartPICC Stylet and PM2+ System. This significant achievement marks a major leap forward in safe, efficient, and cost-effective peripherally inserted central catheter (PICC) placement, offering enhanced benefits for both patients and healthcare providers.
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The SmartPICC technology provides real-time, accurate bedside catheter tip confirmation for PICCs by leveraging the patient’s cardiac electrical activity. This well-established technique eliminates the need for confirmatory chest X-rays, streamlining the PICC confirmation procedure and reducing potential delays in patient care. The SmartPICC Stylet also incorporates Piccolo’s proprietary ionic dilution technology for PICC navigation. This innovative feature provides clinicians with real-time guidance during catheter insertion, allowing for immediate detection of improper advancements through the vasculature.
“The landscape of PICC procedures in the U.S. has evolved, with catheter navigation systems becoming the undeniable standard of care,” stated Augustus Shanahan, CEO of Piccolo Medical, Inc. “However, the widespread adoption of these systems has often come with a significant financial burden on our healthcare system. 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.”
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As part of its commercial strategy, Piccolo Medical has partnered with Spectrum Vascular as the exclusive North American distributor of the SmartPICC system. Spectrum Vascular is a leading provider of vascular access and medication management solutions 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.”
Piccolo Medical is committed to advancing vascular access solutions that improve patient care and optimize healthcare delivery. The FDA clearance of the 2nd generation SmartPICC System reinforces the company’s position as a leader in innovative medical technology.
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Source – PR Newswire
