NEWPORT NEWS, Va. — June 30, 2025 — ivWatch, LLC, the IV safety company, today announced that it has received market authorization under its EU MDR CE Mark for the detection of iron extravasation events by its patented SmartTouch Sensor and IV site patient monitoring system.
This follows the company’s recent receipt of the European Union’s coveted Medical Device Regulation (MDR) Certificate. This certification is necessary for all CE-marked technologies sold in the European Union (EU). It is also leveraged for approval in the United Kingdom (UK), some Gulf Cooperation Council (GCC) countries, and other international markets.
IV iron infusions provide a highly effective alternative to oral iron supplements, particularly in maternity, oncology, and geriatric care, where iron deficiency anemia is common. They are especially beneficial when oral iron is poorly tolerated, causes gastrointestinal side effects, or fails to correct anemia adequately.
Additionally, IV infusions provide a faster and more reliable increase in iron levels, making them ideal for cases that require rapid correction. This is particularly relevant for the estimated 35% of reproductive-age women who are iron deficient. Among those for whom oral supplements are inadequate, IV iron infusions have been shown to successfully treat anemia in approximately 68% of cases.
Vascular access specialist and IV safety advocate Andrew Barton, nurse consultant at Frimley Health NHS Foundation Trust, recently oversaw a trial of ivWatch’s sensor technology in the U.K., which demonstrated a reduction by 100% in the rate of extravasation injury while also increasing the accuracy of vascular injury diagnosis overall.
“Iron extravasations 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,” noted Barton. “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.”
After nearly two years of zero iron extravasations in the Frimley intravenous and vascular access services (IVAS) unit, the use of ivWatch’s advanced IV monitoring technology has now been expanded into the Frimley maternity units at two acute sites.
Barton is also the author of the recently released NIVAS (National Infusion and Vascular Access Society) Infiltration and Extravasation Toolkit, which is designed to highlight the risks of both events and facilitate healthcare organizations’ ability to improve patient safety and experience when it comes to IVs.
ivWatch is the inventor and manufacturer of the only FDA-cleared and CE-marked continuous IV site monitoring technology. The company’s robust patent portfolio has expanded to 69 patents worldwide, protecting its core technologies and reinforcing its commitment to current and future innovations. Its medical device technologies power a real-time monitoring system that notifies clinicians of an IV infiltration or extravasation. Early detection reduces the severity of patient harm which can help improve outcomes. It is currently used in over 60 clinical environments in the U.S., Canada, the United Kingdom, Ireland, Europe, the Kingdom of Saudi Arabia, Qatar, the United Arab Emirates, Kuwait, Australia, and New Zealand.
To see and experience the technology firsthand in the UK, visit the Healthcare21 and ivWatch booth at the 13th annual NIVAS conference, taking place on July 1 and 2, 2025 in Bristol.
About ivWatch
IV insertion is the most common hospital procedure, yet up to 50% of them fail, often with severe consequences ranging from dosing errors, scarring, skin staining, nerve damage, amputation, and even death. Newport News, Virginia-based ivWatch is changing that.
Founded in 2010 and holding nearly 70 patents and counting, the company has developed a first-of-its-kind Class II medical device, cleared by the FDA and CE-marked, that uses visible and near-infrared light and a predictive algorithm to continuously monitor peripheral IVs to aid in the early detection of IV leakage events, also known as infiltration and extravasation.
Applied to the skin at the IV site, ivWatch sensors perform over 18,000 checks per hour for signs of IV infiltration and extravasation, notifying healthcare workers of fluid leakage outside of the vein in real time to reduce severe adverse outcomes.
In 2024, the company surpassed more than 35 clinical proof bodies. It was also named to Fast Company’s Most Innovative Companies list, the Inc. 2024 Best in Business list in the Health Products category, and was recognized by Modern Healthcare as one of its 2024 Best in Business. The company also reached the Top 3 in the 2024 Startup World Cup Grand Finale, from an initial group of over 8,000 global startups. To learn more, visit www.ivwatch.com.