SonarMed, a developer and manufacturer of critical care respiratory monitoring technologies, has received FDA clearance for its patented SonarMed Airway Monitoring System (AMS), which monitors breathing tubes for patients requiring ventilators.
The SonarMed AMS uses acoustic reflection technology to provide real-time monitoring of breathing tubes. The system can be used to assist clinicians in preventing and detecting conditions that can harm the patient, such as movement of the breathing tube, which can result in ventilation failure or lung damage, and obstruction of the breathing tube, which can deprive the patient of needed oxygen.
SonarMed AMS was developed with grant support from the National Institutes of Health (NIH) as well as the state of Indiana’s 21st Century Fund program (21 Fund).
Andrew Cothrel, president and CEO of SonarMed, said: “The SonarMed team, along with its collaboration partners, has worked long and hard toward this critical milestone. There is a significant unmet need in respiratory care today that this system can address, and we are all looking forward to launching the SonarMed AMS and improving the lives of patients who require mechanical ventilation.”
Jeffrey Mansfield, co-founder and CTO of SonarMed, said: “The early strong financial support was crucial to obtain FDA clearance. As with any new medical device development, unexpected challenges arise on the way to FDA clearance. The support of the NIH and the 21 Fund, along with our investors, was crucial to allow us to address those challenges and continue to move forward. Ultimately, this FDA clearance is a win for patients, caregivers, SonarMed, and all of our investors and financial supporters.”