An infant receiving nutrition through an IV cannot tell a nurse that something hurts. A patient under anesthesia may have an IV site hidden beneath surgical drapes for hours.
Those are two of the main high risk situations hospitals have been asking Newport News based ivWatch to address as it expands its continuous IV monitoring technology.
The company has submitted a 510(k) application to the FDA for SmartTouch+, a sensor designed to detect infiltration and extravasation associated with white opaque infusions, including total parenteral nutrition, propofol and other lipid based therapies.
“We kept hearing the same thing from hospitals: some of the infiltration and extravasation injuries they were most concerned about involved therapies we could not yet continuously monitor,” said ivWatch President Erin Wendell. “That was the gap they wanted us to close.”
The filing represents more than another product addition. It is the latest step in ivWatch’s effort to expand the range of therapies its technology can monitor, moving from optically clear fluids to iron sucrose and now toward white opaque infusions.
The limitation has a technical dimension. ivWatch’s monitoring system emits light signals and is processed by a proprietary algorithm. When changes in the tissue surrounding an IV site are detected, the nurse is notified to check the IV site. Earlier company instructions warned that dark, colored or cloudy fluids could block light and reduce the system’s sensitivity. SmartTouch+ is intended to extend monitoring into a category of infusions that has presented that challenge.
Infiltration occurs when IV fluid leaks outside a vein into surrounding tissue. Extravasation involves medications or fluids that can cause tissue damage when they escape the vein. When complications go undetected, the consequences can become serious.
In neonatal intensive care units, infants may receive TPN but cannot communicate discomfort. In operating rooms, patients receiving propofol may have IV sites obscured for extended periods.
“Those are exactly the kinds of situations where relying on periodic visual and tactile checks can be especially challenging,” Wendell said.
When paired with the ivWatch Patient Monitor, SmartTouch+ is designed to perform more than 18,000 checks per hour and alert clinicians to signs that fluid may be leaking outside the vein. The technology is intended to supplement, not replace, regular clinical assessment.
The broader strategy is to reduce the number of therapies for which continuous monitoring is unavailable.
“Our long-term vision is to make continuous IV site monitoring available across as many clinically relevant therapies as possible, helping clinicians identify extravasations earlier regardless of the type of infusion being delivered,” Wendell said.
That ambition has developed incrementally. SmartTouch received FDA clearance in 2020, and the company received expanded clearance for iron sucrose in 2024. The new filing seeks to extend that progression to another category of commonly administered therapies.
SmartTouch+ is not yet FDA cleared and is not available for commercial sale in the United States. If cleared, ivWatch says it will work across patient age groups and integrate with existing IV dressings and clinical workflows.
For hospitals, the potential is another layer of protection in situations where detecting an IV complication can be especially difficult. For ivWatch, it is another step toward making continuous monitoring available wherever patients need it.
