OSI Systems (NASDAQ:OSIS)
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From Jul 2019 to Jul 2024
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.