Propofol

Filing targets TPN, propofol and other IV therapies where undetected infiltration and extravasation can cause severe injury NEWPORT NEWS, Va., Aug. 18, 2026 /PRNewswire/ -- ivWatch, LLC, the IV safety company, today announced it has submitted a 510(k) filing to the U.S. Food and Drug Administration (FDA) for its SmartTouch+™ Sensor, expanding the company's IV monitoring capabilities to detect infiltration and extravasation events associated with both clear and white-opaque fluids early. Despite being one of the most common complications in IV therapy, infiltrations and extravasations frequently go unrecognized until significant harm has occurred. Standard practice still relies on visual and tactile inspection, methods that can miss developing complications for hours. The risk is especially high with white opaque infusions of vesicant medications – drugs capable of causing severe tissue damage when they leak outside the vein. The SmartTouch+ Sensor is designed to expand ivWatch's monitoring platform – which already covers optically clear fluids and iron sucrose – to include lipid-based solutions, such as total parenteral nutrition (TPN), propofol, and other white-opaque fluids. When paired with the ivWatch Patient Monitor, the system performs more than 18,000 checks per hour for signs of infiltration or extravasation and alerts clinicians when fluid may be leaking outside the vein, often hours before they are detectable by visual or tactile examination. "Clinicians and hospitals have been asking us for this expanded capability because they see first-hand that some of the most severe IV extravasation injuries are caused by peripheral infusions of white-opaque fluids, which leads to significant financial burden and risk liability," said Erin Wendell, President, ivWatch. "Our mission is simple – eliminate preventable IV harm. This submission reflects our commitment to meeting market demand, solving a massive global problem with a single solution that provides care teams with monitoring coverage where patients, clinicians and hospitals are most vulnerable." White opaque infusions are part of daily clinical practice across nearly every care setting, each with distinct risks. In neonatal intensive care units, for instance, infants frequently receive Total Parenteral Nutrition (TPN) and are unable to communicate pain at the IV site. In operating rooms, lipid-based medications and sedatives such as propofol are standard parts of care, and IV sites are often obscured by drapes, preventing continuous visual monitoring for extended periods. For these patients, an undetected infiltration can mean the difference between a minor complication and serious injury. Upon FDA clearance, the SmartTouch+ Sensor will work across patient age groups and integrate with existing IV dressings and clinical workflows. Its low-profile, flexible design works in hospitals, infusion centers, and other healthcare facilities, complementing existing ivWatch sensor options for care environments where cloudy infusions are part of everyday care. The company's global intellectual property portfolio includes a robust collection of patents, most recently strengthened by U.S. Patent Application No. 19/334,704 covering SmartTouch+™. SmartTouch+ is patent pending and is currently under review by the U.S. Food and Drug Administration (FDA) following the submission of a 501(k). The sensor is not yet FDA cleared and is not available for commercial sale in the United States. About ivWatch ivWatch is changing IV safety. IV insertion is the most common hospital procedure, yet up to 50% fail, often with severe consequences ranging from dosing errors, scarring, skin staining, nerve damage, amputation, and even death. Founded in 2010 and holding nearly 70 patents, ivWatch has developed a first-of-its-kind FDA-cleared Class II medical device that continuously monitors peripheral IVs to aid in the early detection of infiltration and extravasation events. To learn more, visit . SOURCE ivWatch, LLC 21% more press release views with Request a Demo

Additional Clearance for Masimo SedLine® Empowers Clinicians to Monitor Brain Function and Depth of Sedation in Children with Greater Confidence IRVINE, Calif., July 27, 2026 /PRNewswire/ -- Masimo, a Danaher company and a specialty diagnostics solutions innovator of pulse oximetry and other patient-monitoring solutions, today announced FDA 510(k) clearance for the Patient State Index (PSi) for pediatric patients, the first-and-only sedation score specifically designed for the unique physiology of the pediatric brain, and an example of how Masimo and Danaher are accelerating ideas to impact. A key feature of Masimo SedLine® brain function monitoring, pediatric PSi helps clinicians monitor depth of sedation in children four years and older in the operating room (OR) and intensive care unit (ICU). Children's brains respond differently to anesthesia than adults', making accurate sedation monitoring more challenging.1,2 The newly cleared pediatric PSi addresses that need with an algorithm specifically calibrated and validated for pediatric patients, available to support anesthesiologists for the first time. Pediatric PSi is also the first-and-only index derived from bilateral brain data (as is the PSi for adult patients), and the only index indicated for pediatric use with both propofol and sevoflurane, two of the most common anesthetic drugs. Masimo SedLine helps clinicians monitor brain activity by processing and displaying electroencephalogram (EEG) signals from both halves of the brain, alongside a multi-taper Density Spectral Array (DSA) and PSi, a proprietary, computed EEG variable – providing clinicians with a more complete picture of the brain under anesthesia than competitor technologies. Appropriate depth of sedation monitoring is key to preventing anesthesia-related events and enabling faster recovery.3 "The risks of oversedating pediatric brains are significant," said Professor Zaccaria Ricci, MD, Director of Anesthesiology and the PICU at Meyer Children's Hospital and Associate Professor in the Department of Health Science at the University of Florence, Italy. "Their fragility makes it harder to achieve and maintain appropriate levels of sedation and also increases the chances that oversedation will lead to postoperative complications. Sedating children using standard-of-care dosing guidelines without depth of sedation monitoring is risky – and so too is a one-size-fits-all approach to index-based monitoring." "In Europe, where pediatric SedLine monitoring with the PSi has been available for several years, we have found the index particularly useful in helping us optimize depth of sedation in children and believe it adds significant value to our pediatric anesthesia practices. From a practical perspective, the PSi is also helpful because without it, it's difficult to trend and record brain function data in patient charts, since you cannot trend DSA or raw EEG data," concluded Dr. Ricci. "As we learn more about how children's brains function and respond to anesthesia, the value of sedation monitoring specifically designed for pediatric patients becomes more clear," said Dr. Basil Matta, Chief Medical Officer at Masimo, added. "This FDA clearance is the result of close collaboration with numerous anesthesiologists to solve one of the hardest problems, together: how to equip care teams with the most reliable insights into what is happening in young brains in their most vulnerable moments, when sedated during surgery or in the ICU." "Older technologies rely on unilateral data, or crudely apply algorithms designed for adult brains to children without taking their unique physiology into account. We believe that pediatric PSi, by comparison, offers significant advantages to anesthesiologists, expanding their ability to optimize sedation for children to reduce the risk of oversedation and rate of postsurgical complications. It's a great example of how Masimo is accelerating breakthroughs from discovery to delivery, moving at speed but with clinical and technical rigor to transform ideas into real-world impact," concluded Dr. Matta. Indices like PSi can be particularly helpful in offering quick insight, moment-by-moment, into a patient's brain function under anesthesia – especially when derived from high-quality, comprehensive data and appropriately calibrated for the patient's age group. Masimo PSi also offers the unique ability to be trended and included in the hospital's electronic medical record (EMR). Pediatric SedLine, first cleared by the FDA in 2022, is the only depth of sedation monitoring solution indicated for children as young as one year old. Now, accelerating the impact and reach of brain monitoring technology, clinicians gain the added benefit of index-based insights during the sedation of pediatric patients four years and older, confident in the knowledge that the algorithm driving PSi values was calibrated for that specific use case. Various studies have raised concerns about using sedation scores designed for adults to monitor children's brains4,5 – highlighting the need for more refined scoring solutions and the benefits of an index like PSi customized to reflect pediatric physiology. To achieve this first-ever clearance, Masimo researchers submitted clinical data showing how Masimo's innovative pediatric PSi algorithm – the result of years of careful development and refinement – was equipped to accommodate the unique physiology of children's brains under anesthesia. Using data from 169 pediatric patients, pediatric PSi scoring was shown to be responsive and well correlated with manually scored stages of anesthesia and instances of burst suppression (a sign of potential oversedation, more common in pediatric brains even when exposed to standard-of-care levels of anesthetic drugs).6 Comparison of that data with published data evaluating competitor technology – technology not calibrated for pediatric brains – confirmed pediatric PSi's superior performance.7 In the U.S., SedLine brain function monitoring is indicated for use on adults and on children one year and older; the PSi feature is indicated for use on children four years and older. @Masimo | #Masimo References Davidson et al. Current Anesthesiology Reports 3. 1 (2013): 57-63. Cornelissen L et al. Elife 4 (2015): e06513. Musialowicz et al. Current Anesthesiology Reports 4. 3 (2014): 251-260. Liu JS et al. Variation of bispectral index monitoring in paediatric patients undergoing propofol-remifentanil anaesthesia. Eur J Anaesthesiol. 2008 Oct;25(10):821-5. Sciusco A et al. Effect of age on the performance of bispectral and entropy indices during sevoflurane pediatric anesthesia: a pharmacometric study. Pediatric Anesthesia. 2017 Apr;27(4):399-408. Masimo data on file. Shields C et al. Clinical Utility of the Bispectral Index Score When Compared to the University of Michigan Sedation Scale in Assessing the Depth of Outpatient Pediatric Sedation. Clinical Pediatrics. 2005. doi: 10.1177/000992280504400306. About Masimo Masimo, a Danaher company and a specialty diagnostics solutions innovator of pulse oximetry and other patient monitoring solutions, develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. Our mission is for our innovations to empower clinicians to transform patient care. Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown to outperform other pulse oximetry technologies in over 100 independent and objective studies, which can be found at . Masimo SET® is estimated to be used on more than 200 million patients around the world each year and is the primary pulse oximetry at all 10 top U.S. hospitals as ranked in the 2026 Newsweek World's Best Hospitals listing. Additional information about Masimo and its products may be found at . About Danaher Danaher is a leading global life sciences and diagnostics innovator, committed to accelerating the power of science and technology to improve human health. Through our connected ecosystem of industry-leading businesses, we work side by side with customers to solve many of their most complex scientific and clinical challenges—helping move innovations from discovery to delivery faster for patients who depend on them. Powered by the Danaher Business System, our advanced science and technology and proven ability to innovate help enable faster, more accurate diagnoses and reduce the time, cost, and risk required to discover, develop, and deliver life-changing therapies. Through continuous improvement and operational excellence, our more than 60,000 associates worldwide are focused on delivering lasting impact and improving quality of life around the world, while building a healthier, more sustainable tomorrow. Explore more at . Media Contact: Christine McCullough [email protected] SOURCE Masimo Corporation 21% more press release views with Request a Demo