American peripheral intravenous (IV) device firm ivWatch has announced that it has filed for market clearance from the US Food and Drug Administration (FDA) for a device designed to watch for IV fluid leaks using a predictive algorithm.
Sharing its name with the company, the ivWatch device is intended to use an algorithm alongside extravasation events via its biosensor technology, utilising a multi-spectral light, to detect extravasations at the earliest onset of fluid leaking outside of the vein during iron infusions.
The application for FDA 510(k) clearance comes following a single-arm open-label trial (NCT04064229) consisting of 98 volunteers that was able to demonstrate the system as highly sensitive in detecting iron leaking outside of the vein and into the surrounding tissue. It has also been demonstrated as sensitive to optically clear infusions, detecting infiltrations in amounts as low as 0.2 mL of IV fluid.
The sensor within the device, the ivWatch SmartTouch Sensor, was previously cleared by the FDA and granted an European Union CE marking in 2020 to detect optically clear fluids for all patient ages and skin tones.
President of ivWatch Gary Warren said: “The staining of the skin from iron IV extravasations via one simple event is permanent, and the unfathomable damage can take days or even weeks to fully manifest.
“We are confident that this new expanded capability to detect infiltrating iron will elevate the way that clinicians care for their patients and solve their everyday problems when administering IVs. This is just another example of how we, at ivWatch, listen to our customers to fuel our technology development engine where we relentlessly build great products that perform for clinicians and patients alike by acting as a second set of eyes on IVs.”
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It follows after the company signed a multi-year distribution deal with the US company Marathon Medical in October of 2023. The deal means that the devices would be distributed to Indian Health Service hospitals and clinics, Veterans Affairs hospitals and other federal agencies.