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Columbia-based medical device maker wins FDA approval to sell upgraded single-use bronchoscopes

Ambu, a medical device maker with U.S. headquarters in Columbia, has won federal approval to sell a new generation of single-use bronchoscopes after demand for such products increased during the pandemic.

Regulatory clearance from the U.S. Food and Drug Administration will allow the Danish company to commercialize its new bronchosope products, which come with advanced imaging and design features, including a new high-resolution camera chip, the company said.

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Doctors use bronchoscopes in exams and procedures in the lungs and airways. The company also sells scopes for procedures in the bladder, small intestine and ear, nose and throat.

Reusable medical scopes have been standard in patient care settings, despite isolated reports of contamination. But Ambu saw demand for its disposable endoscopy products surge during the pandemic amid heightened awareness of potential contamination.

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Besides selling the new product in the U.S., Ambu will sell the aScope 5 Broncho in Europe, where it won regulatory clearance in May.

The bronchoscopy health segment is known for complex medical procedures that require scopes of high-performance image quality and handling, Ambu said. It said its fifth-generation bronchoscope has made advances in performance and technology. Because it’s portable, it can be used in settings such as operating rooms, intensive care units and emergency rooms.

Ambu’s new system offers a “complete package” for the bronchoscopy suite, said Ashutosh Sachdeva, director of the interventional pulmonology program at University of Maryland Medical Center in the pulmonary and critical care division.

“The way I see where the field is going, I think this is a bronchoscope of the future,” said Sachdeva, also an assistant professor of medicine at the University of Maryland School of Medicine, in Ambu’s announcement.

Ambu introduced the first-ever flexible, single-use bronchoscope 13 years ago, but earlier versions did not meet some of the more advanced needs in bronchoscopy procedures, said Bassel Rifai, Ambu’s chief marketing officer.


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