Newport News, VA, January 9, 2025 – ivWatch, LLC, the IV safety company, closed out 2024 with major milestones as it expanded its mission to improve IV safety around the globe, laying a strong foundation for continued growth in 2025.
The company surpassed over nine million hours of patient monitoring, and the technology has been used with more than 300,000 patients worldwide, with 53,000 in 2024 alone – a 33% increase from 2023. ivWatch has had 16 successful regulatory audits with no significant findings, is now sold in more than 12 countries, and all product shipments were exactingly manufactured at the company’s Virginia headquarters.
2024 milestones include:
Filings
- ivWatch received an additional 510(k) clearance from the U.S. Food and Drug Administration (FDA) to detect extravasation events via its biosensor technology during iron sucrose infusions.
- The company has been awarded nearly 70 patents globally for its proprietary biosensor technology, which connects to a patient monitor that notifies clinicians to take action if fluid leaks outside a patient’s vein. ivWatch expects more to follow this year as it introduces new products.
Clinical Studies and Evaluations
- 34 product evaluations occurred this year– a 466% increase from the previous year.
- The company surpassed 35 clinical studies including three new third-party validations in 2024 with more underway.
- In the U.K., an NHS Innovation Pathway is underway, with expected approval in Q125. An NHS Innovation Pathway is a structured framework that guides individuals or teams through the process of developing and implementing new healthcare innovations within the NHS, providing support at each stage of the innovation journey, from initial idea conception to full adoption, including navigating regulations, clinical trials, partnerships, funding, and commercialization aspects to ultimately benefit patients; essentially acting as a roadmap to bring new healthcare solutions into practice within the NHS system.
Awards:
- ivWatch reached the Top 3 in the 2024 Startup World Cup Grand Finale, from an initial group of over 8,000 global startups.
- Named to Fast Company’s annual Most Innovative Companies
- Named to the Inc. 2024 Best in Business list in the Health Products category.
- Recognized by Modern Healthcare as one of its Best in Business of 2024.
- Won two MUSE Creative and Design awards for the company’s “Pain Should Not Be Silenced” campaign.
- Chief Marketing Officer, Erin Wendell, was awarded the prestigious Top Women in Marketing Ragan Communications and PR Daily Award. In addition, the PM360 ELITE Award was given to Wendell in the Disruptor category for the creative work her team executed.
- Won DANDA Gold and Bronze awards for Melissa Williams’ IV extravasation victim story.
- For the company’s “Pain Should Not Be Silenced” campaign, named a finalist for a 2024 Fierce Pharma Marketing Award in the Medical Conference or Event Marketing category.
- Awarded multiple Platinum and Gold MarCom Awards for Melissa Williams’ IV extravasation victim story, in the story card, blog post, and video categories.
Global Reach
- Obtained Market Authorization to sell in new areas: Israel, Belgium, and Czech Republic.
- Granted Indications for Use expansion to include iron sucrose infusates in the US, Australia, Saudi Arabia, and Israel.
- ivWatch is now authorized to sell in the USA, Canada, Europe (Austria, Ireland, Netherlands, Belgium, Czech Republic), UK, Israel, Saudi Arabia, Qatar, UAE, Kuwait, Australia, and New Zealand.
- Attendance at multiple conferences around the world, including Arab Health (United Arab Emirates), MEDICA (Germany); American Organization for Nursing Leadership (AONL), American Association of Critical Care Nurses, Association for Vascular Access (AVA), and American Nurses Credentialing Center’s (ANCC) National Magnet & Pathway to Excellence Conferences (U.S.); IV Summit 24, and IV Therapy Summit (U.K.); The National Infusion Center Association (NICA).
- In Saudi Arabia, ivWatch continues to make inroads with the National United Procurement Company (NUPCO), the centralized organization responsible for procuring, storing, and distributing pharmaceuticals, medical equipment, and supplies to public hospitals and medical centers across the country.
- ivWatch is in the final stages of the EU Medical Device Regulation (MDR) process, which is required to sell medical devices in Europe moving forward. The process began in 2018.
Manufacturing
- In December, the company received a perfect financial audit on its supply chain process, with zero findings.
- Because of best-in-class technicians with long tenures at ivWatch, manufacturing continues to perform with an industry-leading <0.7% scrap rate.
- After beginning to manufacture and sell N95 respirators during the pandemic, the company sold 300,000 of them via its e-commerce site in 2024.
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 stop severe IV injuries indefinitely. The system consists of a disposable miniaturized sensor that is 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 www.ivwatch.com.