Health Canada Issues Medical Device License to ivWatch

Surveillance monitoring to advance IV therapy care now available in Canada

HAMPTON, Va., August 2, 2018 – ivWatch, the only 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 (ISO).

To learn more about ivWatch and the Model 400, visit www.ivWatch.com.

About ivWatch:
ivWatch, LLC is the leading medical device manufacturer and biosensor technology company focused on improving patient safety and the effectiveness of intravenous therapy. Our dedicated and passionate team is focused on our company vision of eliminating patient harm caused by infiltrations and extravasations. Through our innovative monitored IV solutions, we help minimize the risks associated with adverse IV events. Follow us on Twitter @ivWatch or Facebook @ivWatchLLChttps://www.ivwatch.com/

MEDIA CONTACT: Amara Betoney, amara.betoney@ivwatch.com, Direct (757) 224-2606, Office (855) 489-2824 x7007, Mobile (757) 660-4949

In the News: The Terror of Medical Errors

ivWatch Discusses Never Events in Healthcare Purchasing News

The Healthcare Purchasing News article with a focus on preventing never events states the exact number and nature of medical errors that occur annually is up for debate. Some events might be underreported and/or important details undisclosed, and that’s often the case for complications involving IVs. Within the piece, ivWatch’s Chief Nursing Officer, Susan Brown, states that despite the best care and internal programs put in place, harm from IV infiltrations and extravasations still occurs due to unique patient factors.

Yet, there’s hope for the future as “many organizations are committed to patient safety protocols and to removing the barriers that prevent accurate, honest reporting of adverse events.” Read the full article here.

In the News: Small Business, Big Impact

ivWatch Featured Among Big Impact Businesses in Hampton Roads

ivWatch was featured among a carefully selected group of Hampton Roads-based companies in a special feature section of CoVa BIZ Magazine. The article introduces the company’s history with beginnings in President and CEO Gary Warren’s basement and covers the journey to FDA clearance for the ivWatch Model 400 as well as continued expansion plans. The article discuss the IV infiltration problem and quotes Warren about the overarching mission to keep patients safe from harm. He states, “It’s rewarding when you can solve an unmet need.” Read the full article here.

In the News: ivWatch Finds Strong Ally in Philips to Monitor Peripheral IVs

Medical Device and Diagnostic Industry Covers ivWatch/Philips Compatibility 

The article, “ivWatch Finds Strong Ally in Philips to Monitor Peripheral IVs” introduces the scope of the complications associated with peripheral IV failure. The piece goes on to highlight the ivWatch Model 400 compatibility with Philips Patient Monitors and the potential to offer time-saving benefits, where ivWatch President and CEO, Gary Warren, touches on the need for more patients to have access to technology for early detection of peripheral IV infiltration, allowing for earlier intervention by the clinician. Read the full article here.

In the News: ivWatch Featured in Drug Delivery Business News

ivWatch Executive Team Quoted in Company Feature in Drug Delivery Business News & MassDevice

On the heels of a compatibility announcement with Philips Intellivue Patient Monitors, Gary Warren, president and CEO of ivWatch, and Scott Hensley, vice president of sales and business development, discuss strategic market partnerships with Drug Delivery Business News. The article discusses how the company is working to solve an unmet need in health care and Warren’s personal patient experiences as inspiration. Read the full article here.

ivWatch Announces Compatibility with Philips IntelliVue Patient Monitors

ivWatch Model 400 includes point-of-care connectivity

HAMPTON, Va., June 21, 2018 – ivWatch, the only provider of continuous non-invasive monitoring devices for the early detection of peripheral intravenous (IV) infiltrations and extravasations, now supports Philips IntelliVue Patient Monitors for in-room and remote notifications and electronic medical record (EMR) data capture.

“Interoperability with an industry leader like Philips enables IV infiltration alerts and IV assessment data to be more widely available to health care providers,” said Gary Warren, president and CEO of ivWatch.

Already an FDA-cleared standalone device that can be integrated with any infusion pump or IV gravity infusion, the ivWatch Model 400 provides infiltration notifications through the Philips IntelliBridge EC10 Interface Module or IntelliBridge EC10 integral Interface Board with Open Interface Driver (ED101) and EC5 ID Module on MP40-90 and MX400-800 Philips patient monitors.

ivWatch visual notifications alerting clinicians of infiltration events can be displayed on a designated Philips patient monitor, as well as generated on remote nursing station monitors allowing care providers to respond quickly. Early detection of these complications helps minimize harm. In addition, a clinician is able to document the overall state/health of the IV or if there was an infiltration directly from the Model 400 user interface during a patient assessment. Integration with Philips technology enables health care facilities to leverage their current infrastructure and capture the IV assessment data in their existing EMR systems.

“Our vision is to eliminate harm associated with IV infiltrations and extravasations,” said Warren. “We will continue to work with like-minded companies to make this technology solution available to as many health care organizations as possible as we embark on a new IV therapy standard of care.”

To learn more about ivWatch and the Model 400, visit www.ivWatch.com.

About ivWatch:
ivWatch, LLC is the leading medical device manufacturer and biosensor technology company focused on improving patient safety and the effectiveness of intravenous therapy. Our dedicated and passionate team is focused on our company vision of eliminating patient harm caused by infiltrations and extravasations. Through our innovative monitored IV solutions, we help minimize the risks associated with adverse IV events. Follow us on Twitter @ivWatch or Facebook @ivWatchLLChttps://www.ivWatch.com/

MEDIA CONTACT: Amara Betoney, amara.betoney@ivwatch.com, Direct (757) 224-2606, Office (855) 489-2824 x7007, Mobile (757) 660-4949

ivWatch Logo White

Download Our Whitepaper

Thank you for requesting more information about the ivWatch Clinical Studies. The ivWatch Model 400 is the only continuous monitoring device for the early detection of IV infiltration and extravasation events.

[fc id='6'][/fc]

You have Successfully Subscribed!

Pin It on Pinterest