Respiratory Motion Inc., a privately held medical device company headquartered in Waltham, said it got a regulatory go-ahead for its ExSpiron respiratory monitoring system.
As a result of receiving a 510(k) clearance from the US Food and Drug Administration, the company said it now expects that the ExSpiron will be available for clinicians beginning in January 2013.
The device provides continuous, noninvasive minute ventilation data in non-ventilated patients. Minute ventilation data are the amounts of air that enter and leave the lungs every minute. According to Respiratory Motion, such quantitative measures of breathing have not been previously available to doctors “across the continuum of care” for patients not hooked up to a ventilator.
In the hospital setting, changes in breathing status often precede deterioration towards respiratory depression and arrest. And respiratory depression can sometimes occur in response to medications, such as narcotic pain-killers and sedatives commonly administered after surgery.
“Averting respiratory failure via early detection can reduce catastrophic events, improve patient care and outcomes, decrease health care costs, and save lives,” the company said in a press release.
Respiratory Motion claims that the ExSpiron can provide warnings of possible breathing problems earlier than other devices now commonly used.
In a statement, Dr. Jenny E. Freeman, Respiratory Motion’s chief executive, said: “Respiratory Motion’s ExSpiron provides the same volume metrics that physicians have come to rely on to manage patients on mechanical ventilators. We are now making these measurements continuously available for non-ventilated patients via a small, noninvasive bedside monitor. Respiratory Motion Inc. has been created to develop technologies to assist clinicians in their fight against respiratory depression and help improve patient safety.”