Mindray's AS3000(TM) Anesthesia Delivery System Receives U.S. FDA Clearance
12 Giugno 2008 - 6:44PM
PR Newswire (US)
SHENZHEN, China, June 12 /Xinhua-PRNewswire-FirstCall/ -- Mindray
Medical International Limited (NYSE:MR) ("Mindray"), a leading
developer, manufacturer and marketer of medical devices worldwide,
announced today that it has received 510(k) clearance from the
United States Food and Drug Administration (the "FDA") for its
AS3000 next generation anesthesia delivery system (the "AS3000")
developed by Datascope Patient Monitoring, a Mindray company
("DPM"). "We're optimistic about the addition of this powerful
anesthesia workstation to our growing portfolio of FDA approved
medical devices and comprehensive suite of product offerings," said
Mr. David Gibson, DPM's president. "The AS3000 enables us to expand
our base of physiologic monitoring throughout the peri-operative
environment, increase our market share in the anesthesia delivery
systems market and further strengthen our leading position in
ambulatory surgery centers and community hospitals." The AS3000
delivers precision anesthesia and ventilation assistance with an
intuitive design developed to bring a higher level of ergonomics to
the operating room. The AS3000 is designed specifically to
penetrate the anesthesia delivery systems market within the U.S.,
which is a market that the company estimates will generate
approximately US$250 million in 2008. The system provides enhanced
inhalation anesthesia and ventilation support capabilities for a
variety of anesthesia cases and critical care settings, including
hospitals, health clinics, outpatient and ambulatory surgery
centers, specialty and surgical hospitals. The new system can be
easily integrated with existing DPM monitors including the recently
launched Spectrum OR and Gas Module III and will notably expand
market coverage of the DPM Anesthesia product line. "The high
quality, competitively priced AS3000 is a testimony of our
commitment to leverage a global R&D platform in order to tailor
products by functionality and price and move up the value chain,"
said Mr. Xu Hang, Mindray's chairman and co-chief executive
officer. "We're encouraged by this approval, the combined efforts
of our world-class China-based and DPM engineering teams and the
future potential of this complementary fit of assets." Mindray
noted that this FDA clearance is part of the company's strategic
focus to gain market share within the peri-operative markets which
has been strengthened by the acquisition of Artema Medical and the
recent release of the Spectrum OR anesthesia monitor. Mindray has
to date received FDA 510(k) clearance for a total of 16 products,
covering patient monitoring and life support products, in-vitro
diagnostic products and medical imaging systems; DPM has to date
received FDA 510(k) clearance for a total of 9 products. About
Mindray Medical International Limited Mindray is a leading
developer, manufacturer and marketer of medical devices worldwide.
Established in 1991, Mindray offers a broad range of products
across three primary business segments: patient monitoring &
life support products, in-vitro diagnostic products and medical
imaging systems. Mindray is globally headquartered in Shenzhen,
China, with U.S. headquarters in Mahwah, New Jersey. Mindray also
has sales and service offices internationally in Amsterdam,
Istanbul, London, Mexico City, Moscow, Mumbai, Sao Paulo, Seattle,
Toronto and Vancouver. For more information, please visit
http://www.mindray.com/ . About Datascope Patient Monitoring DPM
develops, manufactures and markets proprietary patient monitoring
products and medical devices for clinical healthcare markets in
cardiology, radiology, anesthesiology, emergency medicine and
critical care. The company's products are sold throughout the world
through direct sales representatives and independent distributors.
Acquired by Mindray in May 2008, DPM is headquartered in Mahwah,
New Jersey. For more information, please visit DPM's website at
http://www.datascopemonitors.us/. Safe Harbor Statement This press
release contains "forward-looking statements" within the meaning of
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. Statements that are not historical facts,
including statements about new product releases and regulatory
approvals are forward- looking statements. Readers are cautioned
that these forward-looking statements are only predictions and may
differ materially from actual results due to a variety of factors.
Forward-looking statements involve inherent risks and
uncertainties. Information regarding these risks and uncertainties
is included in our public documents filed with the Securities and
Exchange Commission. For a discussion of some of the risks and
important factors that could affect Mindray's actual results and
financial condition, see "Risk Factors" in Part I, Item 3D of
Mindray's Annual Report on Form 20-F for the fiscal year ended
December 31, 2006 and "Operating and Financial Review and
Prospects" in Part I, Item 5 of Mindray's Annual Report on Form
20-F for the fiscal year ended December 31, 2006. All information
and forward-looking statements provided in this press release are
as of June 12, 2008, and Mindray undertakes no duty to update such
information or forward-looking statements, except as required under
applicable law. For investor and media inquiries please contact: In
US: Thomas Bielan Chief Financial Officer Datascope Patient
Monitoring, a Mindray company Tel: +1-800-288-2121 Website:
http://www.datascopemonitors.us/ In China: Susan Du Mindray Medical
International Limited Tel: +86-755-2658-2518 Email: DATASOURCE:
Mindray Medical International Limited CONTACT: In the US: Thomas
Bielan, Chief Financial Officer of Datascope Patient Monitoring, a
Mindray company, at +1-800-288-2121; In China: Susan Du of Mindray
Medical International Limited, +86-755-2658-2518, or Web site:
http://www.mindray.com/ http://www.datascopemonitors.us/
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