ivWatch announced today that it received a new FDA 510(k) clearance for its SmartTouch infusion detection and monitoring technology. Clearance covers the detection of iron sucrose extravasation events by the patented SmartTouch sensor and patient monitoring system. It expands the ivWatch system’s ability to better monitor and detect IV extravasations, improving IV safety across more […]
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ivWatch inks distro deal for IV monitoring device
ivWatch said this week that it landed an international partner to manage the distribution of its continuous intravenous monitoring device. The Hampton, Va.-based company inked a deal with supplier New Medical to distribute its ivWatch Model 400 system in Australia and New Zealand. ivWatch’s sensor, which is roughly the size of a pencil eraser, uses light to […]
ivWatch inks development, commercialization deal with ICU Medical
ivWatch said today that it inked a long-term development and commercialization deal to integrate its continuous IV monitor into new medical devices and systems made by ICU Medical (NSDQ:ICUI). The deal paves the way for EHR interoperability, according to ivWatch, by connecting the two companies’ systems and enabling the exchange of data. “Our two companies can […]
ivWatch wins CE Mark for continuous IV site monitor
ivWatch said today that it won CE Mark clearance for its intravenous infiltration/extravasation monitoring device. The company’s ivWatch Model 400, which has FDA clearance, is sold in the U.S. through group purchasing contracts with Premier and Vizient. ivWatch also touted that it obtained ISO 13485:2016 certification through the Medical Device Single Audit Program. “Peripheral IV […]
Medtech stories we missed this week: August 3, 2018
From Esaote launching its new ultrasound device to Nipro’s Infraredx launching in Japan, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Esaote launches new ultrasound devices Esaote announced in an Aug. 2 press release that it has launched its new MyLab X7, MyLab X6 and MyLab X5 ultrasound systems. […]
ivWatch wins medical device license in Canada
ivWatch said today that it landed a medical device license from Health Canada permitting the sale of its intravenous infiltration/extravasation monitoring device. The company’s FDA-approved sensor, which is roughly the size of a pencil eraser, uses light to measure the optical density of the tissue surrounding an IV insertion site, monitoring the flow of fluid […]
ivWatch to integrate IV infiltration sensor into Philips’ patient monitors
For decades, nurses have sent drugs surging through a patient’s body using the power of the circulatory system. Catheters deliver medications destined to travel through a person’s veins – but it doesn’t always turn out that way. Sometimes, leaky veins cause drugs to seep into surrounding tissue or to back out of the insertion site, […]
Medtech stories we missed this week: Sept. 29, 2017
From EOI getting FDA clearance to Sanuwave’s new joint venture agreement, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. EOI wins FDA nod for FLXfit15 expandable cage EOI announced in a Sept. 28 press release that it has received FDA 510(k) clearance for its FLXfit 15. The clearance […]
ivWatch raises $14.8m for infusion therapy tech
ivWatch said today that it closed a $14.8 million financing round to support the company’s direct go-to-market initiatives and strategic partners activities. Undisclosed angel investors, family funds and a major hospital system invested in the round, according to the company. “The support ivWatch has seen from our investors and partners has been incredible. They are […]
