ivWatch SmartTouch™ Sensor Receives FDA Clearance

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ivWatch, LLC, a pioneer in biosensor technology, announced it has received FDA clearance for their new SmartTouchTM disposable sensor for the early detection of peripheral IV infiltration and extravasation events. This new FDA clearance expands the ivWatch® sensor portfolio to provide hospitals, infusion centers, and other healthcare facilities with complementary sensor solutions to help improve patient safety and reduce the risks associated with IV therapy. With an estimated 46 million high-risk peripheral IVs given in the U.S. every year, ivWatch is the only company to provide hospitals with a continuous IV site monitoring solution.1

Designed with direct clinician input, SmartTouchTM is a single-use sensor that is cleared for all patient age groups. The new miniaturized and disposable sensor adds functionality options for IV site placement, particularly for neonates, for monitoring IV sites of more active patients, and for longer dwell times. The flexible, low-profile sensor includes a breathable adhesive to work seamlessly with existing IV dressings. When paired with the ivWatch Patient Monitor, a proprietary signal processing algorithm continuously measures changes in the optical properties of the tissue near an IV insertion site and simultaneously accounts for patient motion. The ivWatch Patient Monitor provides notification to clinicians of infiltration and extravasation events often hours before they are detectable by visual or tactile examination.2

“At ivWatch, we believe that every patient deserves the highest level of care. We are on a steadfast mission to advancing patient safety by minimizing harm caused by IV therapy. Having continuous IV site monitoring available in all hospital departments is critical to our mission,” said Gary Warren, President, and CEO of ivWatch. “We recognize that all clinical scenarios vary and we are proud to provide clinicians with IV site monitoring tools that are intuitive, complementary to current clinician processes, and equipped to provide reliable guidance and notification so that together we can help reduce the harm associated with IV complications.”

ivWatch sensors use visible and near-infrared light to measure changes in the optical properties of the tissue near a peripheral IV insertion site and SmartTouch can detect infiltrations of as little as 0.2 mL of IV fluid, with an average detection volume of 2.02 mL.3 Such acute perception can be the difference between minor discomfort and a major patient IV injury.

“The most important aspects in developing our cutting-edge SmartTouch Sensor were to ensure our design was just as reliable as our current offering, to incorporate clinical and user experience feedback, and to provide new sensor options to exceed clinician and patients’ varying clinical needs,” said Jaclyn Lautz, Ph.D., Vice President of Research and Development at ivWatch. “With our unwavering commitment to improve patient safety through both our biosensor technology and our user interface experience, we are helping hospitals achieve better patient outcomes.”

A series of seven IRB-approved studies were conducted to test the efficacy and safety of the SmartTouch Sensor. Five verification studies were conducted to understand the performance and optimize ivWatch’s proprietary algorithm to maximize sensitivity to infiltrated tissues, while limiting the number of false notifications issued. Two validation studies were conducted to investigate device sensitivity and false notification rates.

Clinical data shows that the SmartTouch Sensor issued notifications for 99.0%* of early stage infiltrations in less than 10 mL of infused IV fluid. Results also showed less than one false notification was issued every six days, therefore having minimal contribution to clinician alarm fatigue.3,4,5  The majority of the non-infiltration notifications were attributed to a force applied to the IV site, which may beneficially notify clinicians of conditions that could place the peripheral IV site at a greater risk for complications. ivWatch also has a proven record of detecting IV infiltrations an average of 15 hours before the clinician.2

In addition to the launch of SmartTouch, ivWatch is releasing an update for the intuitive user interface on the ivWatch Patient Monitor, which will enhance the clinician and patient experience. The interface will include upgrades such as a new event history log that clearly showcases the state of the IV, audiologist-approved tones and adjustable volumes, and the ability to adjust brightness levels to offer adaptability to various clinician and patient needs.

Along with FDA clearance, the new SmartTouch Sensor has also received the CE Mark and is available internationally. To learn more about SmartTouch and other ivWatch monitoring solutions, visit ivWatch.com and follow the company on various social platforms for the latest updates.


References

1 Fletcher Spaght, Inc. (2016) ivWatch Addressable Market: Analysis and Online Survey Results.
2 Doellman, D. and Rineair, S. (2019) The use of optical detection for continuous monitoring of pediatric IV sites. Journal of the Association for Vascular Access: Summer 2019, Vol. 24, No. 2, pp. 44-47.
3 ivWatch, LLC. (2019). ivWatch SmartTouchTM Sensor: Device validation for infiltrated tissues. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04064229.
4 ivWatch, LLC. (2019). ivWatch SmartTouchTM Sensor: Device Validation for Non-Infiltrated Tissues. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04065373. 
5
 AAMI Foundation Healthcare Technology Safety Institute, Safety Innovations: Using data to drive alarm system improvements, AAMI Foundation, 2012.

*97/98, 95% confidence interval: 94.5% to 100.0%

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