Mindray's Laptop-size M5 and BS-200 Receive FDA Clearance
31 Marzo 2008 - 2:40PM
PR Newswire (US)
Company Announces Update on Product Approval Pipeline SHENZHEN,
China, March 31 /Xinhua-PRNewswire/ -- Mindray Medical
International Limited (NYSE:MR) today announced it has received
510(k) clearance from the United States Food and Drug
Administration ("FDA") for its portable M5 ultrasound imaging
system and BS-200 automatic bio-chemistry analyzer. Mindray has to
date received FDA 510(k) clearance for a total of 14 products,
covering patient monitoring and life support products, in-vitro
diagnostic products and medical imaging systems. The company also
announced it has received approval from the Chinese State Food and
Drug Administration ("SFDA") for the M5 and its DC-3 color
ultrasound imaging system and provided an update on its product
approval pipeline. "Our growing portfolio of FDA-approved medical
devices reflects our commitment to achieving the highest standards
in quality and performance and is part of our long-term strategy to
compete in the most sophisticated markets in the world," said Mr.
Xu Hang, Mindray's chairman and co-chief executive officer. "Our
unique, China-based model leverages world-class R&D that
tailors products by functionality and pricing needs for more than
140 countries worldwide. With our established direct sales and
service network in the United States and Europe expanded by our
recent acquisition, I'm optimistic about our ability to deepen
Mindray brand awareness and continue to gain market share." Latest
product launches and approvals In the first quarter of 2008,
Mindray's portable M5 ultrasound imaging system received both FDA
and SFDA approval and has been launched in both domestic and
international markets. The M5 is the company's first laptop-size
ultrasound imaging device, weighing only six kilograms and
combining brilliant color imaging with uncompromised 2D
performance. Hand Carried Ultrasound ("HCU") is one of the fastest
growing ultrasound segments in the United States and in
international markets. The M5 is ideally suited for doctors'
offices, clinics and surgery centers that traditionally forego
ultrasound imaging equipment due to space and applicable technology
constraints. The company's BS-200 automatic bio-chemistry analyzer
also received FDA clearance in the first quarter of 2008 and is
available in domestic and international markets. The BS-200 is an
automatic low-throughput bio-chemistry analyzer designed to replace
semi-automatic bio-chemistry analyzers. It is targeted for
hospitals and clinics in rural China as well as small hospitals and
labs in international markets. It also serves as a backup machine
for large hospitals and labs. The DC-3 color ultrasound imaging
system, designed to have wide applications in abdominal, OB/GYN,
endovaginal, cardiac, small parts and pediatric markets, received
SFDA approval in the first quarter of 2008. The product is ideally
suited for hospitals and clinics seeking to replace black and white
ultrasound imaging systems. New approval pipeline During the fourth
quarter of 2007, the company submitted applications for FDA
approval for three of its BeneView series products, including the
T5, T6 and T8 multi-parameter patient monitoring devices. The
company expects to receive SFDA approval for its EX55 and EX65
compact anesthesia machines in the second quarter of 2008. About
Mindray Mindray Medical International Limited is a leading
developer, manufacturer and marketer of medical devices in China
with a significant and growing presence 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 headquartered in Shenzhen, China, and has 29 local sales and
service offices in China, as well as sales and service offices in
Amsterdam, Istanbul, London, Mexico City, Moscow, Mumbai, Sao
Paulo, Seattle, Toronto and Vancouver. For more information, please
visit http://www.mindray.com/ . 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. Mindray does not
undertake any obligation to update any forward-looking statement,
except as required under applicable law. All information provided
in this press release is as of March 31, 2008, and Mindray
undertakes no duty to update such information, except as required
under applicable law. For investor inquiries please contact: In
China: Susan Du Mindray Medical International Limited Tel:
+86-755-2658-2518 Email: Justin Knapp Ogilvy Public Relations
Worldwide, Beijing Tel: +86-10-8520-6556 Email: In the United
States: Jeremy Bridgman Ogilvy Public Relations Worldwide, New York
Tel: +1-212-880-5363 DATASOURCE: Mindray Medical International
Limited CONTACT: In China: Susan Du of Mindray Medical
International Limited, +86-755-2658-2518, or ; Or Justin Knapp of
Ogilvy Public Relations Worldwide, Beijing, +86-10-8520-6556, or ;
Or In the United States: Jeremy Bridgman of Ogilvy Public Relations
Worldwide, New York, +1-212-880-5363
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