Saudi Arabia grants ivWatch Market Authorization, according to an announcement by ivWatch, LLC, the creator of the world’s first and only continuous IV site monitoring solution. The Kingdom of Saudi Arabia’s Food & Drug Authority (SFDA) has granted a three-year authorization under MDMA #GHTF-2021-1272 for the company’s products and services. This move is part of ivWatch’s international expansion and further cements their leadership in the IV site monitoring space. The company has also entered into an exclusive agreement with Tamer Group, a leading distributor of medical and healthcare products in Saudi Arabia, to distribute ivWatch technologies and provide training and support. This authorization follows ivWatch’s receipt of FDA clearance and CE mark for its SmartTouchTM disposable sensor in 2020.
Introduction
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.
Statement from Gary Warren
Expansion Efforts and Partnerships
“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 the market.
Product Innovation and Recognition
Learn More
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
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.
Question & Answer
What is the significance of the Market Authorization granted by Saudi Arabia to ivWatch?
Saudi Arabia granted ivWatch Market Authorization under MDMA #GHTF-2021-1272, allowing the company to expand internationally and solidify its leadership in IV site monitoring.
What exclusive agreement did ivWatch enter into in Saudi Arabia?
ivWatch entered into an exclusive agreement with Tamer Group, a prominent distributor of medical products in Saudi Arabia, to distribute ivWatch technologies and provide training and support.
What product innovation did ivWatch achieve in 2020?
In 2020, ivWatch received FDA clearance and CE mark for its SmartTouchTM disposable sensor, which uses visible and near-infrared light to continuously monitor IV insertion sites for early detection of infiltrations.