The US-based creator of the “world’s first and only continuous intravenous [IV] site monitoring solution” has been granted market authorisation by the Saudi Food and Drug Authority (SFDA), it has been announced.
Virginia’s ivWatch – which received a US FDA clearance and CE mark for its SmartTouch disposable sensor last year – has just received a three-year Medical Device Marketing Authorization (MDMA) by the Kingdom.
The company has now entered into an exclusive agreement with Saudi medical and healthcare product distributor, Tamer Group, to manage sales and provide in-service training and support.
“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 minimise adverse events in IV therapy,” said President and CEO, Gary Warren. “We are honoured 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 LARGER CONTEXT
This latest SFDA registration is reportedly in line with ivWatch’s strategy to expand to international markets.
Its advanced disposable SmartTouch miniaturized biosensor utilises visible and near-infrared light to “continuously measure changes in the optical properties of the tissue near an IV insertion site.” The proprietary algorithm can detect “infiltrations early in as little as 0.2 mL of IV fluid”, the company states, “with an average detection volume of 2.02 mL” as well as simultaneously accounting for patient motion.
“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,” it claims on its website.
ON THE RECORD
“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, VP of Business Development and Emerging Markets. “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.”