MediPines Corporation announced that it has received FDA 510(k) market clearance on its new non-invasive medical device, the MediPines Gas Exchange Monitor. The MediPines Gas Exchange Monitor provides clinicians with real-time pulmonary parameters and insights to support rapid triage and treatment decisions for respiratory conditions.
The MediPines Gas Exchange Monitor is the first technology of its kind to integrate a comprehensive set of respiratory parameters and innovative indices analyzed from a patient’s normal breathing samples in a simple, easy to administer breathing test in only a few minutes.
This non-invasive monitor empowers clinicians by providing point of care information on pulmonary gas exchange previously only available through invasive or complicated methods. The MediPines Gas Exchange Monitor provides critical parameters including respiratory rate, oxygen saturation, pulse rate, respiratory quotient and end-tidal CO2. It is the only device that provides novel indices such as oxygen deficit, conveniently packaged in a single, portable, light weight device.
“This is a result of years of scientific and medical research working with the world-renowned respiratory physiology team led by Dr. John B. West,” says Steve Lee, CEO of MediPines Corporation.
In the US, over 33 million patients suffer from respiratory diseases. Globally, over 350 million patients suffer from chronic to acute respiratory issues ranging from Chronic Obstructive Pulmonary Disease (COPD) to asthma. For published studies and findings, click here.
“This device is a significant step forward in advancing respiratory medicine, providing hospitals with vital respiratory care measurements to aid clinicians in diagnosis and treatment, immediately at the point-of-care,” according to Lee.