Glass solutions
used as Class I medical devices
CORNING, N.Y.; JUNE 4,
2019-Corning Incorporated (NYSE: GLW)
announced today that two of its products - Corning®
Med-X® Glass and
Corning®
Med-Gamma® Glass - are
now registered as compliant with U.S. Food and Drug Administration
(FDA) regulations. This compliance demonstrates Corning's
commitment to supporting public health, safety, and security
through high-quality radiation-shielding glass.
"With this registration, Corning becomes the first
radiation-shielding glass manufacturer on the market to provide its
customers and their end-customers with full compliance and
traceability adhering to FDA requirements," said Pierre-Jean Baron,
general manager, Corning Specialty Glass.
Corning is a world leader in radiation shielding glass solutions
for medical, nuclear, and industrial applications. In partnership
with strategic distributors, equipment manufacturers, and shielding
specialists around the world, Corning developed a comprehensive
radiation shielding range with global production capabilities to
complement its innovative glass solutions portfolio.
As per U.S. regulations, Corning registered with
the FDA for Corning®
Med-X® Glass and
Corning®
Med-Gamma® Glass under
the classification of Radiology devices / Personnel protective
shield. These two glass product categories are used as Class I
medical devices as defined by the FDA.
The FDA is responsible for advancing the public
health by helping to speed innovations that make medical products
more effective and safer. It is also responsible for helping the
public get the accurate, science-based information they need to use
medical products and foods. Corning is engaging with the FDA on
multiple fronts including streamlining adoption of Corning
Valor® Glass, the
company's new, revolutionary pharmaceutical glass packaging.
Information on U.S. regulatory requirements for
Class 1 medical devices can be found in the FDA Device section at
this link:
https://www.fda.gov/medical-devices/importing-and-exporting-devices/importing-us
Caution Concerning
Forward-Looking Statements
The statements contained in this release that are
not historical facts or information and contain words such as
"will," "believe," "anticipate," "expect," "intend," "plan,"
"seek," "see," "would," and "target" and similar expressions are
forward-looking statements. These forward-looking statements are
made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995 and include estimates and
assumptions related to economic, competitive and legislative
developments. Such statements relate to future events that by their
nature address matters that are, to different degrees,
uncertain. These estimates are subject to change and
uncertainty which are, in many instances, beyond our control. There
can be no assurance that future developments will be in accordance
with management's expectations. Actual results could differ
materially from those expected by us, depending on the outcome of
various factors. We do not undertake to update forward-looking
statements.
Some of the risks, uncertainties and other factors
that could cause actual results to differ materially from those
expressed in or implied by the forward-looking statements include,
but are not limited to: the effects of acquisitions, dispositions
and other similar transactions, global business, financial,
economic and political conditions; tariffs and import duties;
currency fluctuations between the U.S. dollar and other currencies,
primarily the Japanese yen, euro, Chinese yuan and South Korean
won; product demand and industry capacity; competitive products and
pricing; availability and costs of critical components and
materials; new product development and commercialization; order
activity and demand from major customers; the amount and timing of
our cash flows and earnings and other conditions, which may affect
our ability to pay our quarterly dividend at the planned level or
to repurchase shares at planned levels; possible disruption in
commercial activities due to terrorist activity, cyber-attack,
armed conflict, political or financial instability, natural
disasters, or major health concerns; unanticipated disruption to
equipment, facilities, IT systems or operations; effect of
regulatory and legal developments; ability to pace capital spending
to anticipated levels of customer demand; rate of technology
change; ability to enforce patents and protect intellectual
property and trade secrets; adverse litigation; product and
components performance issues; retention of key personnel; customer
ability, most notably in the Display Technologies segment, to
maintain profitable operations and obtain financing to fund their
ongoing operations and manufacturing expansions and pay their
receivables when due; loss of significant customers; changes in tax
laws and regulations including the Tax Cuts and Jobs Act of 2017;
the impacts of audits by taxing authorities; and the potential
impact of legislation, government regulations, and other government
action and investigations.
For a complete listing of risks and other factors,
please reference the risk factors and forward-looking statements
described in our annual reports on Form 10-K and quarterly reports
on Form 10-Q.
Web Disclosure
In accordance with guidance provided by the SEC regarding the use
of company websites and social media channels to disclose material
information, Corning Incorporated ("Corning") wishes to notify
investors, media, and other interested parties that it uses its
website
(http://www.corning.com/worldwide/en/about-us/news-events.html) to
publish important information about the company, including
information that may be deemed material to investors, or
supplemental to information contained in this or other press
releases. The list of websites and social media channels that the
company uses may be updated on Corning's media and website from
time to time. Corning encourages investors, media, and other
interested parties to review the information Corning may publish
through its website and social media channels as described above,
in addition to the company's SEC filings, press releases,
conference calls, and webcasts.
About Corning
Incorporated
Corning (www.corning.com) is one of the world's leading innovators
in materials science, with a more than 165-year track record of
life-changing inventions. Corning applies its unparalleled
expertise in glass science, ceramic science, and optical physics
along with its deep manufacturing and engineering capabilities to
develop category-defining products that transform industries and
enhance people's lives. Corning succeeds through sustained
investment in RD&E, a unique combination of material and
process innovation, and deep, trust-based relationships with
customers who are global leaders in their industries.
Corning's capabilities are versatile and
synergistic, which allows the company to evolve to meet changing
market needs, while also helping our customers capture new
opportunities in dynamic industries. Today, Corning's markets
include optical communications, mobile consumer electronics,
display technology, automotive, and life sciences vessels.
Corning's industry-leading products include damage-resistant cover
glass for mobile devices; precision glass for advanced displays;
optical fiber, wireless technologies, and connectivity solutions
for state-of-the-art communications networks; trusted products to
accelerate drug discovery and delivery; and clean-air technologies
for cars and trucks.
Media Relations
Contact:
Kaitlin
Cutler
(607) 974-5331
cutlerk@corning.com
Joe Dunning
(607) 974-5006
dunningjm@corning.com
Investor Relations
Contact:
Ann H.S. Nicholson
(607) 974-6716
nicholsoas@corning.com
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This
announcement is distributed by West Corporation on behalf of West
Corporation clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Corning Incorporated via Globenewswire
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