Health Canada Issues Medical Device License to ivWatch

ivWatch, a provider of continuous monitoring devices for the early detection of intravenous (IV) infiltrations and extravasations, was recently issued a medical device license (MDL) by Health Canada permitting the company to sell the ivWatch Model 400 to Canadian health care organizations.
 
“This is yet another milestone allowing more medical care providers and patients access to a first-of-its-kind technology to minimize harm from peripheral IV infiltration/extravasation events (PIVIEs),” said Scott Hensley, vice president of sales and business development at ivWatch. “Canada is one of the most progressive health care markets in the world and acknowledge PIVIEs as serious safety events. Clinicians understand the need for surveillance monitoring to improve patient safety.”
 
Every infiltration is a medication dosing and delivery error that can impact the patient through prolonged hospital stays, temporary harm or permanent injuries. Beyond the patient safety impact, any of these adverse events may result in increased expenses, significant legal risk and reputation damage for health care providers and facilities.
 
“We’re excited to work with health systems and pediatric hospitals who have quality improvement measures in place and stand ready to implement technology capable of drastically reducing the time to detect a PIVIE beyond what is currently possible by visual and tactile assessment,” said Hensley.
 
The MDL is the final step for Canadian market entry and was preceded by the company’s achievement of ISO 13485 certification, the global standard for medical device quality management systems (QMS) developed by the International Organization for Standardization.
 
ivWatch LLC is a medical device manufacturer and biosensor technology company focused on improving patient safety and the effectiveness of intravenous therapy. Its is focused on a vision of eliminating patient harm caused by infiltrations and extravasations. Through its monitored IV solutions, the company’s products help minimize the risks associated with adverse IV events.