SonarMed Receives FDA Clearance for AirWave

Carmel, IN – SonarMed has announced that they have received FDA 510(k) clearance for their AirWave Monitoring System for neonatal (newborn) and pediatric patients, a new device that provides real-time monitoring of the endotracheal tube, a tube inserted into the windpipe to aid in breathing. The SonarMed AirWave system pioneered the use of acoustic reflectometry to continuously monitor the endotracheal tube for movement and obstruction.

The device pinpoints the exact location of the tip of the tube immediately identifying any obstructions or placement issues. Tubes often move, causing them to come out or go deeper into the lungs, which can cause complications. This technology may allow clinicians to take action before a serious or potentially life-threatening problem occurs.

Each year, up to 36% of patients on life support endure complications related to the poor placement of or obstruction in breathing tubes. When complications occur with premature babies, 31% of those suffer serious harm. Locating and positioning the tube in infants can be extremely challenging and complications are dangerous and costly. A recent clinical study indicated that when a breathing tube comes out unexpectedly in pediatric patients the cost can be over $36,000 per incident.

“Until now, neonatologists have not had a single tool to allow for the detection of blocked, malpositioned or completely dislodged endotracheal tubes, all of which are known to significantly increase both long-term morbidity and mortality. The engineers of SonarMed have applied safe, proven technology to solve all these problems in our smallest, most critical patients through the use of a single unique device,” said Dr. Jamie W. Powers, medical director, Neonatal Intensive Care Unit, Pediatrix Medical Group, Huntington Memorial Hospital.

In fact, more than 90% of physicians surveyed stated that they are dissatisfied with the current methods for identifying obstructions and misplaced tubes.

SonarMed will market the pediatric device to a very select group of top-tier hospitals in the next six months.

Jim Tyree, executive chairman of SonarMed and former president of Abbott Biotech Ventures, praised the SonarMed team. “This is an outstanding accomplishment for the team and while the most urgent need for this device is in the NICU, this very well could become standard of care in all ICUs and operating rooms,” he said.

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