OSI Systems Announces FDA Clearance for U.S. Sale and Distribution of Diagnostic Cardiology Data Management System
08 March 2007 - 12:00AM
Business Wire
OSI Systems, Inc. (Nasdaq:OSIS), a vertically-integrated provider
of specialized electronic products for critical applications in the
Security and Healthcare industries, announced today that its
Healthcare Division, Spacelabs Healthcare, has received 510(k)
clearance from the U.S. Food and Drug Administration (�FDA�) to
distribute in the U.S. its new Cardiology Data Management system,
Sentinel. Sentinel integrates the entire range of non-invasive
diagnostic cardiology solutions, including: ECG Exercise Testing,
12-Lead ECG, Holter Monitoring, ECG Event Recording and Ambulatory
Blood Pressure Monitoring into one central data management system.
The system enables a straightforward approach to consolidation and
management of diagnostic cardiology procedures by centralizing all
solutions in a central networked database that reduces the need for
paper records, increases time saved in searching for patient
details and improves workflow management. The system has been
designed for use either in a single station, such as within a
physician's office, or as a fully scalable solution for large
multi-centered hospitals. It is fully networkable and compatible
with existing systems and third party vendor applications. Sentinel
is also designed to integrate with existing hospital information
systems, allowing seamless connectivity of patient records from
admission through recording, diagnosis and discharge. Patient
reports can be viewed at workstations or via the web from any
location through secured security software. Deepak Chopra, Chairman
and Chief Executive Officer of OSI Systems, stated, �We are excited
about achieving 510(k) clearance for Sentinel, our new Cardiology
Data Management system. We believe that Sentinel provides
physicians with an uncompromised facility to perform and to track
the full range of diagnostic cardiology procedures from both
internal and third party vendors� applications.� 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. About OSI Systems, Inc. OSI Systems, Inc. is a Hawthorne,
Calif.-based vertically-integrated provider of specialized
electronic products for critical applications in the Security and
Healthcare industries. 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. About
Spacelabs Healthcare Spacelabs Healthcare, Inc.
(www.spacelabshealthcare.com) is an international developer,
manufacturer and distributor of medical equipment and services,
including patient monitoring solutions, anesthesia delivery and
ventilation systems, diagnostic cardiology solutions and supplies
and accessories selling to hospitals, clinics and physicians
offices. Additionally, the Company provides ECG laboratory services
to pharmaceutical companies undertaking clinical trials, whereby
patient ECG data is recorded, analyzed, tabulated and interpreted.
The Company employs approximately 1,250 personnel in offices
located in the U.K., Canada, India, France, Germany, Finland,
Singapore and the United States. 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 Sentinel Cardiology Data
Management System. 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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