Is the MediPines Gas Exchange Monitor cleared by the FDA?

Yes, the device has received 510(k) clearance as the MediPines Gas Exchange Monitor (generic name of the product). The product model name given is AGM100®.

How do you use the device?

You simply turn on the monitoring unit, and apply a single patient breathing circuit, nose clip, and pulse oximeter finger sensor to the patient. Have your patient breathe normally through the mouthpiece, at rest for approximately two minutes. The device outputs all relevant measurements in real time and breathing session results are displayed on the screen.

What is included with the device?

The MediPines Gas Exchange Monitor (AGM100®) system is comprised of:

  1. Portable monitoring unit
  2. Reusable pulse oximeter probe
  3. Single patient use nose-clip
  4. Single patient use breathing circuit

What is the typical usage of this device?

The MediPines Gas Exchange Monitor is the first of its kind in measuring pulmonary gas exchange. Gas exchange is relevant for assessing and determining respiratory conditions (impaired gas exchange, pneumonia, hypoxia, etc.). The device can be used to determine respiratory measurements in qualified professional healthcare facilities for any cooperative patient that needs gas exchange evaluated and can breathe on their own. If using supplemental oxygen, patient needs to be able to safely come off of oxygen for a few minutes as determined by qualified clinicians for the typical duration of the test.

What clinical benefit will this provide?

The MediPines Gas Exchange Monitor empowers clinicians with a rapid, convenient way to assess patients’ gas exchange on the spot. An immediately actionable data set is provided to support treatment choices by clinicians when dealing with all respiratory cases where impaired gas exchange is present. It is beneficial to clinicians looking for innovative solutions to speed respiratory assessment and provide rapid, safe, accurate, non-invasive, and clinically important information on patient gas exchange.

How will it be beneficial to our facility?

The MediPines Gas Exchange Monitor is portable and designed for point-of-care use in critical and chronic care settings. It provides a simple portable solution without the traditional need for a complicated testing technology and associated facility requirements.

What sets the MediPines Gas Exchange Monitor apart from other methods for measuring pulmonary gas exchange?

The Gas Exchange Monitor is non-invasive, providing clinicians with information on patient gas exchange previously only available through invasive or complicated methods. It provides critical parameters in real-time, unavailable in other devices.

What parameters/indices does it provide?

  1. Oxygen Deficit—Breath-based index of gas exchange inefficiency that is the difference between alveolar and arterial oxygen levels, mmHg
  2. PETO2—End-tidal oxygen partial pressure, mmHg
  3. PETCO2—End-tidal carbon dioxide partial pressure, mmHg
  4. PIO2—Partial pressure of inspired oxygen, mmHg
  5. Pbar—Barometric pressure of ambient air, mmHg
  6. Respiratory Rate (RR)—The number of patient breaths per unit time
  7. gPaO2™—Calculated arterial pressure of oxygen, mmHg
  8. gPaO2™/FiO2—Ratio of arterial partial pressure of Oxygen to fraction of oxygen inspired, mmHg
  9. gPaO2™/PAO2—Arterial to alveolar partial pressure oxygen exchange ratio, dimensionless
  10. Respiratory Quotient (RQ)—The ratio between the amount of carbon dioxide (CO2) produced in metabolism and oxygen (O2) used, dimensionless
  11. Functional Oxygen Saturation (%SpO2)—The percentage of oxygen saturated hemoglobin relative to total hemoglobin in arterial blood
  12. Pulse Rate (PR)—The number of times the heart beats per minute

Which parameters are directly measured, and which are calculated? 

Direct measurements are: PIO2, PETO2, PETCO2, RR, PR, SpO2, Pbar

Calculated measurements are: Oxygen Deficit, gPaO2™, gPaO2™/FiO2, gPaO2™/PAO2, RQ

Who invented the MediPines Gas Exchange Monitor (AGM100®)?

MediPines Corporation collaborated with a Dr. John B. West led, team of respiratory physicians and scientists at the University of California, San Diego to realize the product concept (MediPines) and clinical validation (UCSD).  Dr. West pioneered the original concept of pulmonary gas exchange monitoring.  MediPines Corporation then developed the device and brought it through to FDA clearance. The MediPines Gas Exchange Monitor received FDA 510(k) clearance in the first quarter of 2019.

What clinical evidence is available?

Several significant clinical research studies have been conducted and results are published in peer-reviewed journals. Currently, medical researchers in the US and Canada are conducting further utility studies in various critical hospital applications. For more information, see the peer-reviewed articles published by researchers as listed.

What are the purchase options?

Direct purchase and monthly lease options are available. For more information, contact MediPines.

How do I learn more about this device?

For a product demonstration, purchase and trial discussions contact MediPines.