The company’s device uses ultrasound, which will allow a feeding tube to be placed without need for a surgical setting. With regulatory approval, it’s taking a key step toward commercialization.
Baltimore-based medical device startup CoapTech reached a key milestone in April: It can now market its product that allows the placement of a feeding tube without the need for an operating room.
The company, which was founded out of the University of Maryland, Baltimore, received clearance from the U.S. Food and Drug Administration. The approval it received, called 510(k), demonstrates that devices are safe and effective. When startups are working through clinical trials and preparing regulatory submissions, it’s FDA clearance they’re ultimately seeking.
The company was born as Dr. Steven Tropello, an emergency medical physician at the University of Maryland School of Medicine who is a cofounder of the company along with CEO Howard Carolan as well as its chief medical officer, saw patients who cannot eat or swallow waiting for days for a specialist or operating room to free up so they could have a “G-tube” placed. The process also often requires special imaging.
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