
An acquisition wasn’t the only milestone this year for a local team working on technology to help patients continue to breathe when their lungs aren’t working properly.
The Breethe system, which was initially developed by a surgeon at Baltimore’s University of Maryland School of Medicine, received clearance from the U.S. Food and Drug Administration late last month.
Medical device company Abiomed said in October that the system, which is designed to behave like a human lung, has received the regulatory clearance that allows it to be marketed in the U.S. FDA clearance is often a key hurdle that allows companies to begin selling, and Breethe has completed all testing required before going to market. The product will be introduced in the U.S. through a “controlled rollout” to hospitals, an Abiomed spokesperson said.
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