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FDA clears Spacelabs new sidestream gas analyzer

Spacelabs Healthcare, a subsidiary of OSI Systems, has obtained 510(k) approval for its new compact, sidestream gas analyzer, Capnography Pod, from the US Food and Drug Administration (FDA).

Capnography Pod, which is compatible with the company’s qube patient monitor, 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.

The company said healthcare facilities are now using 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.

Spacelabs Healthcare president Nicholas Ong said Capnography is used for enhancing patient safety particularly with regard to patients who control their pain medication via pump.

"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," Ong added.

OSI Systems CEO Deepak Chopra said, "This capnography module is a key component that will expand the use of the new qube monitor across many departments of the hospital."