Healthcare Industry News:  ventilator 

Devices Monitoring FDA

 News Release - May 11, 2010

SonarMed Receives FDA Clearance for Respiratory Product

INDIANAPOLIS--(HSMN NewsFeed)--SonarMedô, a developer and manufacturer of critical care respiratory monitoring technologies, announced that it has received Food and Drug Administration clearance for its patented SonarMedô Airway Monitoring System (AMS), which monitors breathing tubes for patients requiring ventilators.

The SonarMed AMS uses acoustic reflection technology to provide precise, 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.

Compared with the conventional standards of care and available patient information, having this type of adjunctive information about the breathing tube provides clinicians with a more immediate and complete picture of the patient's respiratory support status.

"We are very pleased with and proud of this accomplishment," said Andrew Cothrel, SonarMed president and CEO. "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."

The system 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).

"Realizing the rewards of hard work and dedication is part of what the 21st Century Fund is all about," said Mitch Roob, secretary of commerce and chief executive officer of the Indiana Economic Development Corporation. "The recent FDA clearance is further proof that SonarMed's technology has the potential to improve the quality of life for respiratory patients around the world."

Early institutional investors include SpringMill Venture Partners and BioCrossroads' Indiana Seed Fund, which was formed to be a source of critical preventure capital for promising Indiana life sciences companies.

"SonarMed is the first Indiana Seed Fund investment to receive FDA clearance for their product. It is a significant milestone both for their company and for our fund," said Nora Doherty, chief financial officer of BioCrossroads and the Indiana Seed Fund managing director. "SonarMed's leadership and their scientific team have worked very hard to commercialize their innovative technology, and they're now one step closer to bringing an important medical product to market."

Dr. Jeffrey Mansfield, SonarMed co-founder and CTO, said that 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," Mansfield said. "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."

The technology was developed at Purdue University in the laboratory of George R. Wodicka, professor and head of the Weldon School of Biomedical Engineering. It was licensed through the Purdue Research Foundation's Office of Technology Commercialization.

"It is gratifying to know that technology invented by a team of biomedical researchers at Purdue, as further developed and commercialized by SonarMed, is now moving a step closer to the hospital where it can help critical care patients," Wodicka said. "The SonarMed AMS technology exemplifies our goal of discovery with delivery."

Source: SonarMed

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