Healthcare Industry News:  ventilator 

Devices Monitoring FDA

 News Release - August 15, 2012

Spacelabs Healthcare Receives 510(k) Clearance for Sidestream Capnography Module

ISSAQUAH, Wash.--(Healthcare Sales & Marketing Network)--Spacelabs Healthcare today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its Capnography Pod – a compact, sidestream gas analyzer compatible with the company’s new qubeTM patient monitor. The Capnography Pod provides a non-invasive method of measuring the concentration of carbon dioxide in a gas mixture, to aid in determining the patient’s ventilatory, circulatory and metabolic status during conscious sedation or under anesthesia.

Healthcare facilities now embrace the use of capnography beyond the outpatient/day-surgery areas to include the monitoring of patients during procedural sedation for gastrointestinal endoscopy and those who are receiving patient-controlled analgesia.

“Capnography is widely recognized as enhancing patient safety particularly with regard to patients who control their pain medication via pump,” said Nicholas Ong, President of Spacelabs Healthcare. “This is a very valuable tool that allows caregivers to be notified, for example, if a patient’s breathing is becoming compromised as a result of overmedicating.”

Spacelabs’ capnography module fits seamlessly onto the qube patient monitor. qube offers portability, accessibility and heightened connectivity – from bedside throughout transport – and is a recent addition to Spacelabs’ Art of Monitoring portfolio that also includes the XPREZZONTM patient monitor, AriaTeleTM digital transmitters, and ICS XPREZZTM mobile app for iPad.

About Spacelabs Healthcare, Inc.

Spacelabs Healthcare, Inc. (www.spacelabshealthcare.com), a wholly-owned subsidiary of OSI Systems, Inc., is an international developer, manufacturer and distributor of medical equipment and services including solutions for patient monitoring and connectivity, anesthesia delivery and ventilation, diagnostic cardiology and supplies and accessories selling to hospitals, clinics and physician offices. The Company has offices in the United States, United Kingdom, Canada, France, Germany, Italy, China, India and Singapore and distribution partners in more than 100 countries around the world.

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 the Company’s expectations, goals or intentions about the future, including, but not limited to, statements regarding the performance of the Company’s products. The actual results may differ materially from those described in or implied by any forward-looking statement. Other important factors are set forth in the Securities and Exchange Commission filings of OSI Systems, Inc. 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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