ivWatch Files 510(k) with FDA for SmartTouch+™ Sensor, Expanding Continuous IV Monitoring to White-Opaque Infusates

Filing targets TPN, propofol and other IV therapies where undetected infiltration 
and extravasation can cause severe injury 

NEWPORT NEWS, Va., Aug. 18, 2026 /PRNewswire/ -- ivWatch, LLC, the IV safety company, today announced it has submitted a 510(k) filing to the U.S. Food and Drug Administration (FDA) for its SmartTouch+™ Sensor, expanding the company's IV monitoring capabilities to detect infiltration and extravasation events associated with both clear and white-opaque fluids early.

Despite being one of the most common complications in IV therapy, infiltrations and extravasations frequently go unrecognized until significant harm has occurred. Standard practice still relies on visual and tactile inspection, methods that can miss developing complications for hours. The risk is especially high with white opaque infusions of vesicant medications – drugs capable of causing severe tissue damage when they leak outside the vein.

The SmartTouch+ Sensor is designed to expand ivWatch's monitoring platform – which already covers optically clear fluids and iron sucrose – to include lipid-based solutions, such as total parenteral nutrition (TPN), propofol, and other white-opaque fluids. When paired with the ivWatch Patient Monitor, the system performs more than 18,000 checks per hour for signs of infiltration or extravasation and alerts clinicians when fluid may be leaking outside the vein, often hours before they are detectable by visual or tactile examination.

"Clinicians and hospitals have been asking us for this expanded capability because they see first-hand that some of the most severe IV extravasation injuries are caused by peripheral infusions of white-opaque fluids, which leads to significant financial burden and risk liability," said Erin Wendell, President, ivWatch. "Our mission is simple – eliminate preventable IV harm. This submission reflects our commitment to meeting market demand, solving a massive global problem with a single solution that provides care teams with monitoring coverage where patients, clinicians and hospitals are most vulnerable."

White opaque infusions are part of daily clinical practice across nearly every care setting, each with distinct risks. In neonatal intensive care units, for instance, infants frequently receive Total Parenteral Nutrition (TPN) and are unable to communicate pain at the IV site. In operating rooms, lipid-based medications and sedatives such as propofol are standard parts of care, and IV sites are often obscured by drapes, preventing continuous visual monitoring for extended periods. For these patients, an undetected infiltration can mean the difference between a minor complication and serious injury.

Upon FDA clearance, the SmartTouch+ Sensor will work across patient age groups and integrate with existing IV dressings and clinical workflows. Its low-profile, flexible design works in hospitals, infusion centers, and other healthcare facilities, complementing existing ivWatch sensor options for care environments where cloudy infusions are part of everyday care.

The company's global intellectual property portfolio includes a robust collection of patents, most recently strengthened by U.S. Patent Application No. 19/334,704 covering SmartTouch+™.

SmartTouch+ is patent pending and is currently under review by the U.S. Food and Drug Administration (FDA) following the submission of a 501(k). The sensor is not yet FDA cleared and is not available for commercial sale in the United States.

About ivWatch
ivWatch is changing IV safety. IV insertion is the most common hospital procedure, yet up to 50% fail, often with severe consequences ranging from dosing errors, scarring, skin staining, nerve damage, amputation, and even death. Founded in 2010 and holding nearly 70 patents, ivWatch has developed a first-of-its-kind FDA-cleared Class II medical device that continuously monitors peripheral IVs to aid in the early detection of infiltration and extravasation events. To learn more, visit www.ivwatch.com.

SOURCE ivWatch, LLC