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.

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