Glass solutions used as Class I medical devices
CORNING, N.Y.; JUNE 4, 2019-Corning Incorporated (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:
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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.
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.
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Source: Corning Incorporated via GlobeNewswire