Market Overview

ivWatch Receives CE Mark for the ivWatch Model 400


Recent regulatory approvals and global certification pave the way for
international distribution

the only provider of continuous monitoring devices for the early
detection of intravenous (IV) infiltrations and extravasations,
announced the CE marking of the ivWatch Model 400. In addition to
conforming to European standards, the company obtained ISO 13485:2016
Certification through the Medical Device Single Audit Program (MDSAP), a
global standard for medical device quality management systems. The
first-of-its-kind and FDA-cleared device is currently sold in the U.S.
through direct sales by ivWatch utilizing group purchasing contracts
from Premier and Vizient, Inc.

"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," said Gary Warren,
president and CEO of ivWatch. "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."

MDSAP enables medical device manufacturers to contract with an
authorized third-party auditing organization to conduct a single
audit which satisfies all regulatory authorities in a given market. In
addition to the U.S. FDA, other authorities participating in the program
include those in Australia, Brazil, Canada and Japan. These achievements
come only weeks after ivWatch was issued
a medical device license
by Health Canada, and supports an ongoing licensing
and distribution partnership
with Terumo Corporation in Japan.

Because the ivWatch Model 400 continuously monitors the IV site, it
offers a significantly improved measure of security to a standard,
unmonitored peripheral IV, thereby also reducing costs associated with
wasted medications and adverse events. Reliable early detection and
notifications of infiltration is the next step for improving patient
outcomes during IV therapy.

To learn more about ivWatch and the Model 400, visit

About ivWatch:

 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 @ivWatchLLC

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