Oridion Systems, a medical device company, has received the FDA 510(k) clearance for its Capnostream20 Monitor with Integrated Pulmonary Index.
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According to the company, the Integrated Pulmonary Index, the latest Oridion Smart Capnography initiative, utilizes sophisticated algorithms to integrate the real time measures and interactions of four complex parameters – end tidal CO2, respiration rate, pulse rate and SpO2 into a single index value. The result is displayed on a scale from 1-10, where 10 indicates optimal pulmonary status.
By using the Integrated Pulmonary Index, clinicians can quickly and easily assess a patient’s ventilation status and monitor a patient’s changing condition, thus facilitating more timely interventions to reduce patient risk and improve outcomes, the company said.
Gerry Feldman, president of Oridion, said: We are encouraged and delighted by this FDA clearance. Oridion has worked hard to develop safer and easier patient safety technologies. The Integrated Pulmonary Index will make sophisticated determinations of pulmonary adequacy far more efficient for the diagnosing clinician. More importantly, it will enable the general floor nurse to confidently decide when to call for help.
Oridion Systems is a medical device company specializing in patient safety monitoring. The Company operates through wholly owned subsidiaries in the United States, Europe, and Israel. Oridion develops proprietary medical devices and patient interfaces, based on its patented Microstream technologies, for the enhancement of patient safety through the monitoring of the carbon dioxide in a patient’s breath.
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