Piccolo Medical® Receives FDA Clearance to Expand ECGuide™ Technology Use to Pediatric and Neonatal Patients

SAN FRANCISCO, Nov. 18, 2025 /PRNewswire/ -- Piccolo Medical, Inc. (Piccolo) today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the Indications for Use for its PM2^™ System and ECGuide^™ Connector. This clearance extends the technology's use as an alternative to chest x-ray for a variety of central venous access devices in pediatric and neonatal patient populations.

The ECGuide^™ technology provides real-time, accurate catheter tip positioning by utilizing the patient's cardiac electrical activity (ECG). This method provides an alternative to traditional radiological confirmation, significantly reducing the patient's exposure to ionizing radiation and improving hospital efficiency. This benefit is especially critical for pediatric and neonatal patients, who are more vulnerable to the cumulative effects of radiation and often require multiple chest x-ray images for a single catheter confirmation.

The expanded indication allows for bedside confirmation of central venous access devices including peripherally inserted central catheters (PICCs), central venous catheters (CVC), hemodialysis catheters and ports. Bedside catheter tip confirmation using intravascular ECG has been shown to improve clinical workflow, avoid delays in therapy, and provide accurate tip position confirmation.

"This crucial milestone demonstrates our commitment to helping the most vulnerable and underserved patient populations," said Augustus Shanahan, CEO of Piccolo Medical. "Neonatal and pediatric providers face unique challenges, with limited devices designed and indicated specifically for their needs. We are proud to offer clinicians a product that lets them choose the right catheter for the patient without compromising. This is the only way to improve the standard of care in the NICU and pediatric units."

This new clearance builds upon the ECGuide^™ technology's existing FDA clearance for use in adult patients, further solidifying Piccolo Medical's portfolio of solutions designed to reduce complications, improve patient safety, and drive economic value in vascular access.

About Piccolo Medical, Inc.
Piccolo Medical, Inc. is a medical device company based in San Francisco, CA. Piccolo was spun out of the Theranova medical device incubator and has been funded by private investors as well as prestigious grant awards from the National Institutes of Health's Eunice Kennedy Shriver National Institute of Child Health and Human Development. Piccolo Medical is committed to developing and commercializing innovative vascular access technologies designed to improve clinical outcomes, streamline procedures, and reduce complications for patients. Spectrum Vascular is the exclusive distributor of Piccolo Medical technologies.

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SOURCE Piccolo Medical