#United States #San Francisco #FDA Clearance #Piccolo Medical #SmartPICC®

Piccolo Medical Receives FDA Clearance for Enhanced PICC Technology

On July 16, 2025, Piccolo Medical, an innovator in vascular access solutions, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its next-generation SmartPICC® Stylet and PM2+™ System. This accomplishment signifies a substantial advancement in the efficiency and safety of peripherally inserted central catheter (PICC) placements, presenting significant advantages for both patients and healthcare professionals.

The SmartPICC® technology uses the patient's cardiac electrical activity to provide real-time, accurate tip confirmation of the catheter. This feature does away with the necessity for confirmatory chest X-rays, streamlining the entire process and minimizing potential delays in patient care. Furthermore, the SmartPICC® Stylet is equipped with Piccolo's proprietary ionic dilution technology that guides clinicians during catheter insertion. This guidance allows for immediate detection of any inappropriate advancement through the vascular system, enhancing overall procedural accuracy and safety.

Augustus Shanahan, CEO of Piccolo Medical, emphasized the changing dynamics in the U.S. PICC procedure landscape, stating, "The implementation of catheter navigation systems has become a non-negotiable standard of care. However, this progress has often come with hefty financial implications for our healthcare system. We are proud to present a comprehensive solution that not only prioritizes patient safety but also adds real economic value for hospitals through efficient bedside PICC confirmation."

To facilitate the distribution of this innovative system, Piccolo Medical has partnered with Spectrum Vascular, which is now the exclusive North American distributor of the SmartPICC® system. Spectrum Vascular is known for its commitment to providing advanced vascular access and medication management solutions to hospitals nationwide.

Ken Miller, CEO of Spectrum Vascular, stated, "Our mission is to deliver exceptional vascular access solutions that bolster patient outcomes while supporting caregivers. By incorporating Piccolo's SmartPICC® navigation technology, we enable clinicians to enhance their precision and efficiency at the bedside, which in turn reduces complications and enriches care quality."

Piccolo Medical remains committed to enhancing vascular access technologies that improve patient care and healthcare delivery efficiency. The recent FDA clearance of its second-generation SmartPICC® System solidifies the company's status as a pioneer in innovative medical technology.

About Piccolo Medical

Piccolo Medical Inc. is a startup located in San Francisco, CA, focused on medical device development. It originated from the Theranova medical device incubator and has received funding from private investors as well as grants from the National Institute of Health's National Institute on Aging. Just last year, Piccolo achieved 510(k) clearance for its ECGuide™ Connector and PM2™ System.

About Spectrum Vascular

Spectrum Vascular acquired the vascular access segment of Cook Medical in 2023 and Angiodynamics in 2024. With innovation at its core, Spectrum Vascular strives to harness deep industry knowledge and contemporary medical technology advancements to push the limits of vascular access solutions, ultimately aiming to fulfill the evolving needs of healthcare providers and patients alike.

For further inquiries or more information, visit Piccolo Medical's website or Spectrum Vascular's website.