Healthcare Industry News: Spacelabs Healthcare
News Release - March 7, 2007
Spacelabs Healthcare Announces FDA Clearance for U.S. Sale and Distribution of Diagnostic Cardiology Data Management System
HAWTHORNE, CA--(Healthcare Sales & Marketing Network)--Mar 7, 2007 -- Spacelabs Healthcare, Inc. (LSE:SLAB.L ), an international medical equipment company listed on the London AIM market, announced today that it 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, Chief Executive Officer Spacelabs Healthcare, 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 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 UK, 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.
Source: Spacelabs Healthcare
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