ivWatch, a medical device manufacturer and biosensor technology firm, has secured CE mark approval for its ivWatch Model 400 device to continuously monitor intravenous (IVs).
Image: The ivWatch Model 400 has secured CE mark approval. Photo: courtesy of Business Wire.
The ivWatch Model 400 has been developed for continuous IV monitoring for the early detection of infiltration and extravasation events to enhance patient safety and minimize harm.
The device is provided with ivWatch patient monitor for monitoring and notifications, as well as reusable sensor cable that uses visible and near-infrared light.
ivWatch Model 400 also features disposable receptacle, which is placed next to the peripheral IV to secure the sensor to the patient.
The ivWatch monitor will provide audible and visual notifications, if changes in the optical properties of the tissue near the PIV insertion site are consistent with an infiltration.
Earlier this month, the company also secured medical device license (MDL) from Health Canada to sell the ivWatch Model 400 to Canadian health care organizations.
Previously, the ivWatch Model 400 also secured approval from the US Food and Drug Administration (FDA), which is the first-of-its-kind device in the US.
In the US, the device is marketed via direct sales by ivWatch utilizing group purchasing contracts from Premier and Vizient.
The firm has also established a licensing and distribution partnership with Terumo for the device in Japan.
ivWatch president and CEO Gary Warren said: “Peripheral IV therapy is among the most common invasive hospital procedures performed worldwide. Having the ability to extend the only surveillance monitoring technology for early detection of these common IV complications to new markets will help improve patient safety and effectiveness of IV therapy on a much larger scale.
“Navigating the comprehensive process to secure these regulatory milestones not only makes ivWatch positioned for growth but gives us the ability to respond quickly to new opportunities.”
The company has also secured ISO 13485:2016 certification through the Medical Device Single Audit Program (MDSAP), a global standard for medical device quality management systems.
MDSAP allows medical device manufacturers to contract with an authorized third-party auditing organization to carry out a single audit to satisfy all regulatory authorities in a given market.
The authorities from Australia, Brazil, Canada and Japan are also involved in the program, in addition to the US FDA.