ivWatch announced today that it received a new FDA 510(k) clearance for its SmartTouch infusion detection and monitoring technology.
Clearance covers the detection of iron sucrose extravasation events by the patented SmartTouch sensor and patient monitoring system. It expands the ivWatch system’s ability to better monitor and detect IV extravasations, improving IV safety across more types of infusions.
ivWatch develops and manufactures continuous IV site monitoring technology. The medical device technologies power a real-time monitoring system that notifies clinicians of an IV infiltration or extravasation. It helps to reduce patient harm while improving outcomes in IV therapy.
A trial of the technology in the UK showed a 100% reduction in the rate of extravasation injury while accuracy of vascular injury diagnosis increased. Andrew Barton, a nurse consultant at Frimley Health NHS Foundation Trust oversaw that trial.
Barton said: “Iron extravasations, in particular, can be devastating for the patient as the damage can take days or even weeks to manifest fully and leads to permanent skin staining, not to mention the psychological damages to the patient that come from these lifelong effects. Prior to the introduction of ivWatch in my unit, we were seeing 2-3 extravasations per week, and we now do not have any injuries, which saves money and time and is brilliant for patient safety. ivWatch technology is now a standard of care in my unit which has played a major role in the early identification of extravasations and treatments.”
FDA clearance comes just after the company inked a partnership with the National Infusion Center Association (NICA). It also partners a number of patient safety organizations around the globe.
