Masimo Announces First CE-marked Third-party Masimo Open Connect® Module for the Root® Patient Monitoring and Connectivity ...
April 29 2019 - 2:00AM
Business Wire
Masimo (NASDAQ: MASI) and Mdoloris Medical Systems
announced today the CE marking of the Mdoloris Analgesia
Nociception Index (ANI®) module for the Masimo Root® Patient
Monitoring and Connectivity Hub, the first commercially available
result of a Masimo Open Connect® (MOC) third-party partnership,
between Mdoloris and Masimo.
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the full release here:
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Masimo Root® with Next Generation
SedLine® Brain Function Monitoring and Mdoloris ANI® (Photo:
Business Wire)
Masimo’s unique approach to medical technology integration
through Masimo Open Connect partnerships addresses some of the
major barriers to new technology adoption in patient monitoring.
The Root platform’s open architecture and advanced connectivity
enable third-party companies to bypass barriers and the time it
takes for traditional multi-parameter monitor integration by
controlling their own Root integration projects. Third parties can
then independently develop, obtain regulatory approvals, and
commercialize their own external MOC-9® module or MOC-C® app for
Root using Masimo’s MOC software development kit and support from
Masimo’s engineering and distribution teams.
Joe Kiani, Founder and CEO of Masimo, said, “We are proud to
announce ANI, the first commercially available third-party MOC-9
module for Root, the first of many to come. With the ongoing
expansion of its capabilities, Root becomes a more powerful bedside
platform than ever. We believe that Root with Masimo Open Connect
can do for patient monitoring what the PC did for computing: speed
up the patient monitoring innovation cycle, reduce the cost of
patient monitoring, and prolong the useful life of the equipment
hospitals invest in.”
“We are delighted to be able to announce that ANI is now cleared
for sale in the EU,” said Fabien Pagniez, Founder and CEO of
Mdoloris Medical Systems. “We consider Masimo to be the most
innovative company in the patient monitoring space and we believe
Root offers a unique and compelling solution for implementing our
ANI technology.”
ANI on Masimo Root has not received 510(k) clearance and is not
available for sale in the United States.
@MasimoInnovates | #Masimo
About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative
noninvasive monitoring technologies. Our mission is to improve
patient outcomes and reduce the cost of care. In 1995, the company
debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse
oximetry, which has been shown in over 100 independent and
objective studies to outperform other pulse oximetry technologies.1
Masimo SET® has also been shown to help clinicians reduce severe
retinopathy of prematurity in neonates,2 improve CCHD screening in
newborns,3 and, when used for continuous monitoring with Masimo
Patient SafetyNet™ in post-surgical wards, reduce rapid response
activations and costs.4-6 Masimo SET® is estimated to be used on
more than 100 million patients in leading hospitals and other
healthcare settings around the world,7 and is the primary pulse
oximetry at 9 of the top 10 hospitals listed in the 2018-19 U.S.
News and World Report Best Hospitals Honor Roll.8 In 2005, Masimo
introduced rainbow® Pulse CO-Oximetry technology, allowing
noninvasive and continuous monitoring of blood constituents that
previously could only be measured invasively, including total
hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin
(SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®),
and more recently, Oxygen Reserve Index (ORi™), in addition to
SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo
introduced Root®, an intuitive patient monitoring and connectivity
platform with the Masimo Open Connect® (MOC-9®) interface, enabling
other companies to augment Root with new features and measurement
capabilities. Masimo is also taking an active leadership role in
mHealth with products such as the Radius-7® wearable patient
monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™
fingertip pulse oximeter. Additional information about Masimo and
its products may be found at www.masimo.com. Published clinical
studies on Masimo products can be found at
http://www.masimo.com/evidence/featured-studies/feature/.
ORi has not received FDA 510(k) clearance and is not available
for sale in the United States. The use of the trademark Patient
SafetyNet is under license from University HealthSystem
Consortium.
About Mdoloris Medical Systems
Mdoloris (www.mdoloris.com), a medical devices manufacturer, was
created in June 2010 out of 23 years of academic research performed
in Lille University hospital, France. It has an international
representation in more than 64 countries and a scientific,
technical and medical acknowledgement. Mdoloris has so far
developed three products, all able to continuously assess the pain
level of patients (the ANI technology for patients older than two
years old, the NIPE technology for neonates, and the PTA technology
for pets). Its innovative technologies provide clinical added value
for clinicians who are not able to communicate with their patients
in order to personalize pain medications and avoid known side
effects due to over- and under-dosage of such drugs. More than
1,200 devices are now used by anesthesiologists and intensivists
worldwide and more than 140,000 patients have benefited from
Mdoloris’ technologies. Mdoloris’s standalone monitor promoting its
innovative adult technology has received 510(k) clearance through
the HFVI brand in the US under the number K142969. Mdoloris
recently closed a nine-million euro fundraising round in order to
keep developing new-to-the-world technologies that always keep one
target in mind: helping clinicians improve the quality of care.
References
- Published clinical studies on pulse
oximetry and the benefits of Masimo SET® can be found on our
website at http://www.masimo.com. Comparative studies include
independent and objective studies which are comprised of abstracts
presented at scientific meetings and peer-reviewed journal
articles.
- Castillo A et al. Prevention of
Retinopathy of Prematurity in Preterm Infants through Changes in
Clinical Practice and SpO2 Technology. Acta Paediatr. 2011
Feb;100(2):188-92.
- de-Wahl Granelli A et al. Impact of
pulse oximetry screening on the detection of duct dependent
congenital heart disease: a Swedish prospective screening study in
39,821 newborns. BMJ. 2009;Jan 8;338.
- Taenzer AH et al. Impact of pulse
oximetry surveillance on rescue events and intensive care unit
transfers: a before-and-after concurrence study. Anesthesiology.
2010:112(2):282-287.
- Taenzer A et al. Postoperative
Monitoring – The Dartmouth Experience. Anesthesia Patient Safety
Foundation Newsletter. Spring-Summer 2012.
- McGrath SP et al. Surveillance
Monitoring Management for General Care Units: Strategy, Design, and
Implementation. The Joint Commission Journal on Quality and Patient
Safety. 2016 Jul;42(7):293-302.
- Estimate: Masimo data on file.
-
http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.
Forward-Looking Statements
This press release includes forward-looking statements as
defined in Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934, in connection with the
Private Securities Litigation Reform Act of 1995. These
forward-looking statements include, among others, statements
regarding the potential effectiveness of Masimo Root®. These
forward-looking statements are based on current expectations about
future events affecting us and are subject to risks and
uncertainties, all of which are difficult to predict and many of
which are beyond our control and could cause our actual results to
differ materially and adversely from those expressed in our
forward-looking statements as a result of various risk factors,
including, but not limited to: risks related to our assumptions
regarding the repeatability of clinical results; risks related to
our belief that Masimo's unique noninvasive measurement
technologies, including Masimo Root, contribute to positive
clinical outcomes and patient safety; risks related to our belief
that Masimo noninvasive medical breakthroughs provide
cost-effective solutions and unique advantages; as well as other
factors discussed in the "Risk Factors" section of our most recent
reports filed with the Securities and Exchange Commission ("SEC"),
which may be obtained for free at the SEC's website at www.sec.gov.
Although we believe that the expectations reflected in our
forward-looking statements are reasonable, we do not know whether
our expectations will prove correct. All forward-looking statements
included in this press release are expressly qualified in their
entirety by the foregoing cautionary statements. You are cautioned
not to place undue reliance on these forward-looking statements,
which speak only as of today's date. We do not undertake any
obligation to update, amend or clarify these statements or the
"Risk Factors" contained in our most recent reports filed with the
SEC, whether as a result of new information, future events or
otherwise, except as may be required under the applicable
securities laws.
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version on businesswire.com: https://www.businesswire.com/news/home/20190428005012/en/
MasimoEvan Lamb949-396-3376elamb@masimo.com
MdolorisPierrick
Niewiadowskipierrick.niewiadowski@mdoloris.com
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