Blease Medical Announces FDA 510(k) Approval for Sale and Distribution of Anesthesia Systems into US Market
October 12 2005 - 8:00AM
Business Wire
Blease Medical, a division of OSI Systems, Inc. (Nasdaq:OSIS),
today announced that it had received 510(k) from the U.S. Food and
Drug Administration ("FDA") for the sale of its Sirius 3000 with
8700 ventilator, anesthesia system into the United States market.
Currently, Blease distributes a complete range of anesthesia
systems and ventilators internationally to approximately 90
countries but not currently to the United States. FDA 510(k)
approval clears the way for the company's flagship system to be
sold in the United States, where annual sales of anesthesia systems
and ventilators is approximately $429 million, as estimated by
independent business consultants, Frost & Sullivan. Nicholas
Ong, President of Blease Medical, stated, "We are excited about
achieving 510(k) certification for our Sirius 3000 with 8700
ventilator anesthesia system. Approval by the FDA helps to
facilitate our marketing efforts internationally as the Sirius
product line is now certified by regulatory authorities in both
Europe and the United States. It is our intention to begin working
towards a market launch and introduction in the United States
working closely with Spacelabs Medical where possible, to leverage
off their established presence and distribution network." The FDA
requires that all medical devices introduced to the U.S. be
preceded either by a pre-market notification clearance order under
section 510(k) of the Food, Drug and Cosmetic Act, or an approved
pre-market approval application. A 510(k) pre-market notification
clearance order indicates that the FDA agrees with an applicant's
determination that the product for which clearance has been sought
is substantially equivalent to another legally marketed medical
device. The approval process to obtain certification under section
510(k) took approximately 7 months. About Blease Medical Blease
Medical (www.blease.com), based in Chesham UK, has been a leader in
anesthesia solutions for clinicians for more than 50 years. The
company specializes in the design, manufacture and distribution of
anesthesia systems, vaporizers and ventilators. Blease is a leading
supplier of OEM products and components to the anesthesia industry
worldwide. Blease products are sold internationally in anesthesia,
critical care and emergency care areas. Blease operates from two UK
sites and maintains a UK-based sales and service field force in
addition to distribution partnerships in approximately 80
countries. Blease currently employs approximately 100 people. About
OSI Systems, Inc. OSI Systems, Inc. is a Hawthorne,
California-based diversified global developer, manufacturer and
seller of security and inspection systems, medical monitoring and
anesthesia products, and optoelectronic devices and value-added
subsystems. The company has more than 30 years of experience in
electronics engineering and manufacturing and maintains offices and
production facilities located in more than a dozen countries. OSI
Systems implements a strategy of expansion by leveraging its
electronics and contract manufacturing capabilities into selective
end product markets through organic growth and acquisitions. For
more information on OSI Systems Inc. or any of its subsidiary
companies, visit www.osi-systems.com. This press release contains
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. Such statements
include information regarding our expectations, goals or intentions
about the future, including, but not limited to, statements
regarding the market acceptance of the Sirius 3000 with 8700
ventilator, anesthesia systems. The actual results may differ
materially from those described in or implied by any
forward-looking statement. Other important factors are set forth in
our Securities and Exchange Commission filings. All forward-looking
statements speak only as of the date made, and we undertake no
obligation to update these forward-looking statements.
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