ivWatch Granted Market Authorization by Saudi Arabia Food & Drug Authority
After Continued Success in the Region, Company Advances International Expansion Further into Middle East
NEWPORT NEWS, Va., Sept. 22, 2021 /PRNewswire/ -- Today, ivWatch, LLC creator of the world's first and only continuous IV site monitoring solution announced Medical Device Market Authorization (MDMA) for the company's products and services by the Kingdom of Saudi Arabia's Food & Drug Authority (SFDA). ivWatch gained a three-year authorization for the company under MDMA #GHTF-2021-1272.
"At ivWatch, we are on a global mission to provide hospitals around the world with coveted, proven technology that will add value to the patient safety movement, and also minimize adverse events in IV therapy," said Gary Warren, President and CEO of ivWatch. "We are honored to bring our continuous IV site monitoring innovations to the Kingdom, which is highly committed to elevating and establishing new standards of care; we look forward to seeing our products seamlessly become a key part of the patient safety experience in Saudi Arabia."
The SFDA registration approval continues the Company's expansion efforts and presence in international markets as ivWatch strives to end the problems associated with peripheral IV infiltration and extravasation events around the globe. ivWatch has a diverse patent portfolio further cementing its foothold as the leader in the IV site monitoring space.
"ivWatch's international expansion is a key component of our long-term growth strategy and we are excited about the runway ahead in the Middle East," said Chuck Egress, Vice President of Business Development and Emerging Markets at ivWatch. "Saudi Arabia is laser focused and, on a mission, to advance and transform their healthcare system; we are confident our revolutionary innovations will complement their efforts, so that together we can improve patient outcomes in IV therapy."
ivWatch has entered into an exclusive agreement with Tamer Group, a leading distributor of medical and healthcare products in Saudi Arabia. Tamer Group will leverage their expertise and deep connections to distribute ivWatch technologies to healthcare organizations in Saudi Arabia and provide in-service training and support in market.
In 2020, ivWatch also received FDA clearance and CE mark for its SmartTouchTM disposable sensor. SmartTouch is a single-use, miniaturized biosensor that is cleared for all patient age groups and uses visible and near-infrared light to continuously measure changes in the optical properties of the tissue near an IV insertion site. The proprietary algorithm detects infiltrations early in as little as 0.2 mL of IV fluid, with an average detection volume of 2.02 mL and simultaneously accounts for patient motion.1 When paired with the ivWatch Patient Monitor, notifications alert clinicians of adverse IV therapy events often hours before they are detectable by visual or tactile examination.2
To learn more about ivWatch, visit www.ivWatch.com or follow the Company's social media platforms for the latest updates on new innovations and breakthroughs.
1 ivWatch, LLC. (2019). ivWatch SmartTouchTM Sensor: Device validation for infiltrated tissues. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04064229.
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.
About ivWatch, LLC
ivWatch, LLC is a biosensor technology company focused on improving patient safety and the effectiveness of intravenous therapy. Our dedicated and passionate team is pioneering the use of optical sensors to detect adverse IV events early to minimize the risk of injury caused by infiltrations and extravasations. Our innovative IV site monitoring solutions are backed by decades of clinical research and device development. To learn more, follow us on Twitter @ivWatch, Facebook @ivWatchLLC, LinkedIn @ivWatch or visit www.ivWatch.com.
SOURCE ivWatch, LLC
Share this article