Masimo Announces FDA Clearance of Radius PPG™, the First Tetherless SET® Pulse Oximetry Sensor Solution

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IRVINE, Calif.–(BUSINESS WIRE)–Masimo (NASDAQ:
MASI) announced today FDA 510(k) clearance of Radius PPG, a tetherless
sensor solution powered by Masimo SET® that represents a
significant breakthrough in patient monitoring. Radius PPG eliminates
the need for a cabled connection to a pulse oximetry monitor, allowing
patients to move freely and comfortably while still being continuously
monitored reliably and accurately. Via wireless connection, measurements
are displayed on Masimo host devices or third-party multi-parameter
monitors with integrated Masimo technology, making Radius PPG
immediately available for approximately two million monitors around the
world. Coupled with the proven benefits of Masimo SET®
Measure-through Motion and Low Perfusion pulse oximetry,
Radius PPG is suited for use anywhere patients can benefit from mobility.


Radius PPG gives patients freedom of movement without interrupting
continuous monitoring. Wireless connection to a host device is simple to
establish and each Radius PPG can easily pair with multiple devices
(maintaining connection to any one device at a time), simplifying
transfers between care areas. Radius PPG works with its integrated
battery for about four days and stores up to four days (96 hours) of
patient data; in the event of wireless interruption, Radius PPG provides
seamless retransmission once the connection is restored. Automated by
Masimo’s connectivity solutions, patient data can be used for remote
clinician notifications of changes in patient condition and
automatically transferred to the patient’s EMR.

Studies have shown that patient mobility is a key factor in more rapid
patient recovery.1,2 In addition, the removal of cables has
been shown to contribute to greater patient comfort, convenience, and
patient satisfaction compared to tethered patient monitoring.3
Radius PPG allows patients to move throughout the hospital room, to the
bathroom, and to other care areas without the need for physical
disconnection and reconnection. In places like the neonatal ICU, care
providers and parents can hold infants without interrupting monitoring
or risking an uncomfortable tug on the patient. Radius PPG not only
offers patients improved comfort and convenience but improves clinician
workflows.

Radius PPG harnesses the power of clinically proven Masimo SET® technology
to provide accurate measurement even while patients move. Over 100
independent and objective studies have shown that SET®
outperforms other pulse oximetry technologies during conditions of
motion and low perfusion.4 When used in conjunction with
Patient SafetyNet™, continuous monitoring using SET® in
post-surgical wards has been shown to reduce rapid response team
activations and transfers back to the ICU.5-7 Masimo SET®
has also been shown to help clinicians reduce severe retinopathy of
prematurity (ROP) in neonates8 and improve critical
congenital heart disease (CCHD) screening in newborns.9
Today, Masimo SET® is estimated to be used on more than 100
million patients in leading hospitals and other healthcare settings
around the world,10 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.11

Joe Kiani, Founder and CEO of Masimo, said, “We are excited to announce
the Radius PPG tetherless, wearable SET® pulse oximetry
sensor solution. Accurate, high-quality monitoring data can now travel
from an ambulating patient to a variety of monitoring platforms,
allowing a patient’s physiological status to be continuously monitored
when it’s needed most.”

@MasimoInnovates |
#Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that
develops and produces a wide array of industry-leading monitoring
technologies, including innovative measurements, sensors, patient
monitors, and automation and connectivity solutions. Our mission is to
improve patient outcomes and reduce the cost of care. Masimo SET®
Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in
1995, has been shown in over 100 independent and objective studies to
outperform other pulse oximetry technologies.4 Masimo SET®
has also been shown to help clinicians reduce severe retinopathy of
prematurity in neonates,8 improve CCHD screening in newborns,9
and, when used for continuous monitoring with Masimo Patient SafetyNet™
in post-surgical wards, reduce rapid response team activations, ICU
transfers, and costs.5-7 Masimo SET® is estimated
to be used on more than 100 million patients in leading hospitals and
other healthcare settings around the world,10 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.11
Masimo continues to refine SET® and in 2018, announced that
SpO2 accuracy on RD SET™ sensors during conditions of motion
has been significantly improved, providing clinicians with even greater
confidence that the SpO2 values they rely on accurately
reflect a patient’s physiological status. 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®),
RPVi™ (rainbow® PVi), and Oxygen Reserve Index (ORi™). In
2013, Masimo introduced the Root® Patient Monitoring and
Connectivity Platform, built from the ground up to be as flexible and
expandable as possible to facilitate the addition of other Masimo and
third-party monitoring technologies; key Masimo additions include Next
Generation SedLine® Brain Function Monitoring, O3®
Regional Oximetry, and ISA™ Capnography with NomoLine®
sampling lines. Masimo’s family of continuous and spot-check monitoring
Pulse CO-Oximeters® includes devices designed for use in a
variety of clinical and non-clinical scenarios, including tetherless,
wearable technology, such as Radius-7®, portable devices like
Rad-67™, fingertip pulse oximeters like MightySat® Rx, and
devices available for use both in the hospital and at home, such as
Rad-97™. Masimo hospital automation and connectivity solutions are
centered around the Iris® platform, and include Iris
Gateway™, Patient SafetyNet, Replica™, Halo ION™, UniView™, and
Doctella™. Additional information about Masimo and its products may be
found at www.masimo.com.
Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature/.

ORi and RPVi have not received FDA 510(k) clearance and are not
available for sale in the United States. The use of the trademark
Patient SafetyNet is under license from University HealthSystem
Consortium.

References

  1. Needham D et al. Archives of Physical Medicine and Rehabilitation.
    Vol 91, Issue 4, PP 536–542, April 2010.
  2. Ronnenbaum J et al. J Acute Care Phys Ther. 2012;3(2):204-210.
  3. Fensli R et al. J Med Syst (2010) 34: 767. https://doi.org/10.1007/s10916-009-9291-8.
  4. 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.
  5. 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.
  6. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia
    Patient Safety Foundation Newsletter
    . Spring-Summer 2012.
  7. 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.
  8. 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.
  9. 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.
  10. Estimate: Masimo data on file.
  11. 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 Radius PPG™ and SET®. 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 Radius PPG and SET®,
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.

Contacts

Masimo
Evan Lamb
949-396-3376
elamb@masimo.com

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