Hi-tech medical device company Oridion Systems Ltd. (ORIDN on SWX New Market) announced Tuesday that it has received a 510(k) clearance from the U.S. Food and Drug Administration (FDA) for another one of its capnography products - the Oral/Nasal FilterLine. This product is the first in the company's FilterLine family of patented consumable products to monitor the carbon dioxide released from both the patient's mouth and nose.
The product's technological advantages are especially important for cases in which medical treatment is provided under procedural sedation. Under such circumstances, there is an increased chance of CO2 being exhaled through a patient's mouth - a problem that the firm's latest product addresses.
Oridion developed the product to prevent sampling difficulties and inaccurate CO2 readings that may occur when carbon dioxide is only monitored from a patient's nose, with a conventional nasal cannula.
Oridion Capnography Business Unit's VP of Marketing, LuAnn Joy, said that the use of procedural sedation continues to grow. "Accordingly, new healthcare standards and guidelines continue to emerge in the U.S. and worldwide regarding CO2 monitoring" "We clearly saw the need for a device that would help ensure accurate monitoring in these situations, and help care providers meet these patient safety standards...," she said.
The new product can be used with any of the company's Microstream capnography monitors.