IV Safety Company ivWatch Receives 510(K) Clearance from FDA to Monitor Commonly Administered Iron Infusions

ivWatch Receives Official Federal Supply Schedule Approval to Sell IV Monitoring Technology into Government Healthcare Facilities
February 13, 2024

Technology is now available to the $12B+ infusion therapy market


NEWPORT NEWS, Va. — March 26, 2024  ivWatch, LLC, the IV safety company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the detection of iron sucrose extravasation events by its patented SmartTouch Sensor and patient monitoring system.

Testing results presented to the FDA indicated the system is highly sensitive to iron sucrose extravasations. A key signal parameter to detect extravasation was twice as strong for iron sucrose as for saline, 47.1% versus 23.3%, respectively. This data indicates that the high sensitivity of the sensor to iron sucrose injections, on top of the already high sensitivity for optically clear infusates, is sufficient to update the system’s indications for use, expanding the ivWatch system to better monitor and detect IV extravasations, improving IV safety across more types of infusions and advancing patient safety.

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.

Barton says, “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.”

ivWatch’s 510(k) clearance dovetails with the company’s recent partnership with the National Infusion Center Association (NICA), which is a nonprofit trade association and the U.S. voice for non-hospital, community-based infusion providers that offer a safe alternative to hospital care settings for provider-administered medications. There are approximately 9 million Americans over the age of 65 years old who receive iron infusion treatments each year – almost 1 per every five Medicare recipients – which equates to nearly 117,000 extravasations per year in the United States.*

In addition to NICA, ivWatch is the proud partner of many patient safety organizations including, Patients for Patients Safety, Patients for Safer Nuclear Medicine, and the U.K.’s National Infusion and Vascular Access Society (NIVAS) and also currently has executives serving as active members of the National Patient Safety Board Advocacy Coalition.

​​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. This helps reduce patient harm and improve outcomes in IV therapy. 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.

*Luthra, S. (2019). $2,733 To Treat Iron-Poor Blood? Iron Infusions For Anemia Under Scrutiny. NPR.

About ivWatch, LLC
Founded in 2010 and holding nearly 70 patents, ivWatch 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 and aid in the early detection of IV infiltration and extravasation events. These events are common and can lead to severe consequences ranging from dosing errors, scarring, skin staining, nerve damage, amputation, and even death.

The ivWatch patient monitoring system performs over 18,000 checks per hour for signs of IV infiltration and extravasation, notifying healthcare workers of fluid leaking outside of the vein in real time to reduce severe adverse outcomes. In 2023, the company surpassed more than 30 clinical bodies of evidence.

ivWatch was named one of the World’s Most Innovative Companies 2024 by Fast Company, which also named it the sixth most innovative medical device company globally. It was also awarded a PM360 Innovative Health Award in the Health-Tech/Non-Consumer category and named a Fierce Life Sciences Innovation Award finalist for medical device innovation, both in 2023. To learn more, visit www.ivWatch.com.



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IV Safety Company ivWatch Receives 510(K) Clearance from FDA to Monitor Commonly Administered Iron Infusions – ivWatch