IV Safety Company ivWatch Files 510(K) Clearance to FDA for Monitoring of Iron Infusions

Technology expected to reach market beginning in 2024

Newport News, VA, December 21, 2023 —  ivWatch, LLC, the IV safety company, today announced its filing for 510(k) clearance from the U.S. Food and Drug Administration (FDA) to detect extravasation events via its biosensor technology during iron infusions. ivWatch patient monitoring technology uses a predictive algorithm combined with multi-spectral light to identify extravasations at the earliest onset of fluid leaking outside of the vein to protect patients from unpredictable IV complications.

With the anticipation of the company’s product clearance, the versatility of the technology will seamlessly flow into infusion centers and hospitals around the globe. Iron is typically administered for iron deficient anemic patients. These patients often have fragile veins, commonly in newborns and geriatric patients, and are more susceptible to IVs extravasating. As found in a recent study, the global iron deficiency anemia treatment market reached a value of $9.3 billion in 2020 and is expected to grow to $22.5 billion by 2030. According to market calculations, the iron extravasation problem is affecting at least 90,000 individuals annually across the U.S., ages 65 and older.1

Test results presented to the FDA showed that the system is highly sensitive in detecting iron leaking outside of the vein and into the tissue. The monitoring system has already been proven to be incredibly sensitive to optically clear infusions detecting infiltrations in as little as 0.2 mL of IV fluid, with an average detection volume of 2 mL2. Though the statistical objective of the testing was to show the detection of iron was at least as strong as optically clear injections, the data indicates even higher sensitivity to iron injections across all dilutions. The ivWatch SmartTouch Sensor was initially FDA cleared and granted CE Marking in 2020 to detect optically clear fluids for all patient ages, sizes, skin tones, and peripheral IV sites. The company’s first-generation sensor was first brought to market in 2015 in the adult population and quickly approved for pediatrics in 2016.

“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,” notes Gary Warren, ivWatch’s President and CEO. “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.”

ivWatch is the inventor and manufacturer of the only FDA-cleared and CE Marked continuous IV site monitoring technology with over 30 clinical bodies of evidence. The company’s robust patent portfolio has expanded to 71 patents around the world protecting its core technologies and reinforcing its commitment to current and future innovations. The medical device technologies work as a monitoring system to notify clinicians in real time of an IV infiltration or extravasation, which helps reduce patient harm and improve outcomes in IV therapy. The technology is backed by science with over two decades of research and development, is currently implemented in three of the top ten children’s hospitals in the U.S., and is now available in more than 10 countries around the world.

1Iron Infusions For Anemia Under Scrutiny For High, Widely Varying Prices : Shots – Health News : NPR

 2 ivWatch, LLC. (2019, April). ivWatch SmartTouchTM Sensor: Device validation for infiltrated tissues. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04064229. ClinicalTrials.gov Identifier: NCT04064229

About ivWatch, LLC
ivWatch, LLC  is a biosensor technology company focused on improving patient safety and the effectiveness of intravenous therapy. Our dedicated and passionate team is pioneering the use of optical sensors to detect adverse IV events early to minimize the risk of injury caused by infiltrations and extravasations. By using this technology, clinicians can leverage continuous monitoring to help identify infiltrations as early as possible. Our innovative IV monitoring solutions are backed by decades of clinical research and device development. To learn more, follow us on Twitter @ivWatch, Facebook @ivWatchLLC, Instagram @ivWatchLLC and LinkedIn @ivWatch-LLC, or visit www.ivWatch.com.