Newport News, VA – March 26, 2025 – ivWatch, the IV safety company, today announced its receipt of the European Union’s coveted Medical Device Regulation (MDR) Certificate. The company successfully completed all mandatory steps including Stage 1 and 2 audits, a Technical Documentation review, and a Clinical Evaluation Assessment, resulting in the certificate being issued. This certification is necessary for all CE-marked technologies currently being sold in the European Union (EU) and is also leveraged for approval in the United Kingdom (UK), some Gulf Cooperation Council (GCC) countries, and other international markets.
“ivWatch’s patented technology is strategically expanding with market authorization in key countries around the world, and this milestone allows us to continue to bring advanced monitoring technology to more patients on a global scale,” notes ivWatch’s Vice President of Regulatory Affairs & Quality Assurance Holly Novak. “The rigorous nature of achieving this updated certification required huge dedication from our technical team and represents a previously unprecedented level of scrutiny on the part of the EU, giving our customers in the region unparalleled assurance in our product’s efficacy.”
ivWatch currently has market authorization in the USA, Canada, Austria, Ireland, Netherlands, Belgium, Czech Republic, UK, Israel, Saudi Arabia, Qatar, UAE, Kuwait, Australia, and New Zealand.
In 2024, the company surpassed over nine million hours of patient monitoring. The technology has now been used with more than 300,000 patients worldwide. All product shipments were exactingly manufactured at the company’s Virginia headquarters.
The ivWatch team of experts pushes the boundaries of healthcare standards through its continuous IV site monitoring technology, creating an entirely new product category striving to better patient care and reduce severe IV injuries globally. The system consists of a disposable miniaturized sensor connected to a patient monitor that notifies clinicians if fluid is leaking outside of their patient’s vein. Due to the potential severity of infiltrations, it is critical for clinicians to identify these adverse events as soon as possible to prevent patient injury.
For more information on how the technology works, visit: https://www.ivwatch.com/tech-overview/.
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 bodies of evidence. 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