MASIMO CORPORATION (NASDAQ:MASI) Files An 8-K Other Events
Item 8.01.
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Other Events
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had received a warning letter (the Warning Letter) from the U.S.
Food and Drug Administration (FDA) regarding compliance with
current Good Manufacturing Practices at Masimos Irvine,
California manufacturing facility.
that FDA has completed an evaluation of Masimos corrective
actions in response to the Warning Letter, and that, based on the
FDAs evaluation, it appears that Masimo has addressed the
violations contained in the Warning Letter. The letter indicated
that future FDA inspections and regulatory activities will
further assess the adequacy and sustainability of the
corrections. A copy of the letter is filed as Exhibit 99.1 and is
incorporated herein by reference.
statements as defined in Section 27A of the Securities Act of
1933, as amended, and Section 21E of the Securities Exchange Act
of 1934, as amended, in connection with the Private Securities
Litigation Reform Act of 1995. 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
not limited to: risks related to our assumptions regarding
whether the corrective actions taken have addressed all
violations contained in the Warning Letter, additional or future
actions by or requests from the FDA and unanticipated costs or
delays associated with resolution of these matters; 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 SECs website at
www.sec.gov. Although Masimo believes that the expectations
reflected in our forward-looking statements are reasonable, it
does not know whether our expectations will prove correct. All
forward-looking statements included in this Current Report on
Form 8-K 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 todays date. Masimo does not undertake any obligation
to update, amend or clarify these forward-looking statements or
the Risk Factors contained in Masimos most recent reports filed
with the SEC, whether as a result of new information, future
events or otherwise, except as
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Item 9.01.
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Financial Statements and Exhibits.
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(d) Exhibits
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99.1
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FDA Warning Letter, dated May 25, 2017 and received on
May 26, 2017. |
About MASIMO CORPORATION (NASDAQ:MASI)
Masimo Corporation is a medical technology company that develops, manufactures and markets non-invasive patient monitoring products. The Company’s business is measure-through-motion and low-perfusion pulse oximetry monitoring, known as Masimo Signal Extraction Technology (SET) pulse oximetry. Its product offerings include monitoring blood constituents with an optical signature, optical organ oximetry monitoring, electrical brain function monitoring, acoustic respiration monitoring and exhaled gas monitoring. The Company has developed the Root patient monitoring and connectivity platform, the Radical-7 bedside and portable patient monitor and the Radius-7 wearable wireless patient monitor. It has also developed the Patient SafetyNet remote patient surveillance monitoring system, which allows over 200 patients to be monitored simultaneously and remotely through a personal computer (PC)-based viewing station or by care providers through their voice-over-Internet Protocol (IP) phones.
