Continuous IV monitoring system developer ivWatch announced that it received FDA clearance for its new SmartTouch disposable sensor.
SmartTouch is indicated for the early detection of peripheral IV infiltration and extravasation events. The latest FDA clearance expands ivWatch’s sensor portfolio to include the single-use sensor for all patient age groups. It is miniaturized and disposable and adds functionality options for IV site placement as well, according to a news release.
When paired with the ivWatch patient monitor, the sensor helps to alert clinicians of infiltration and extravasation events often hours before they are detectable by visual or tactile examination, the company said. The Newport News, Va.-based company also issued an update for the user interface of the patient monitor to enhance clinician and patient experience.
Clinical data for the SmartTouch sensor revealed that it issued notifications for 99% of early-stage infiltrations in less than 10mL of infused IV fluid. Less than one false notification was issued every six days, as well.
“At ivWatch, we believe that every patient deserves the highest level of care,” ivWatch president & CEO Gary Warren said in the news release. “We are on a steadfast mission to advancing patient safety by minimizing harm caused by IV therapy. Having continuous IV site monitoring available in all hospital departments is critical to our mission.
“We recognize that all clinical scenarios vary and we are proud to provide clinicians with IV site monitoring tools that are intuitive, complementary to current clinician processes, and equipped to provide reliable guidance and notification, so that together we can help reduce the harm associated with IV complications.”
Just this week, the company also confirmed the sale of $1.5 million in an equity offering that could bring in as much as $13 million for the company.