510(k) clearance for ExSpiron

WALTHAM, MA – Respiratory Motion, Inc. has recived 510(k) clearance from the US Food and Drug Administration (FDA) for its ExSpiron respiratory monitoring system. The device is the first to provide continuous, noninvasive Minute Ventilation data in non-ventilated patients.

ExSpiron provides continuous, accurate quantitative readings of Minute Ventilation (the amount of air that enters/leaves the lungs every minute), which has never before been continuously captures in non-ventilated patients. The device also measures respiration rate (breaths per minute) and tidal volume (the volume of air in a single breath).

The system works by applying a monitoring patch to the chest of a patient, which is connected to an electric monitor. The device automatically begins watching the lungs and displays continuous readings on the monitor.

According to Respiratory Motion, the ExSpiron will be available for clinicians beginning in January 2013 in the initial hospital settings of anesthesia/OR, post-op recovery, and intensive care units.