FDA OKs Ambu’s Fifth-Generation, Single-Use Bronchoscope

Ambu has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its family of aScope 5 Broncho single-use, sterile bronchoscopes. The scopes received European regulatory clearance in May.
 
The aScope Broncho 5 family features advanced imaging and design features, including a new high-resolution camera chip.
 
“With the aScope 5 Broncho system, I am getting a complete package with all the things that I need for it to be my workhorse scope in the bronchoscopy suite. The way I see where the field is going, I think this is a bronchoscope of the future,” Dr. Ashutosh Sachdeva, Director of Interventional Pulmonology Program at University of Maryland Medical Center in the Division of Pulmonary and Critical Care, and Assistant Professor of Medicine at the University of Maryland School of Medicine, told the press.

 
Ambu’s solution can be useful for healthcare providers needing to perform bronchoscopies in a wide range of care settings: the bronchoscopy suite, operating rooms, intensive care units, and emergency rooms.
 
“We introduced the world’s first flexible single-use bronchoscope 13 years ago, breaking new ground in intensive care units and operating rooms worldwide. However, until now, the advanced needs in the bronchoscopy suite were never met by single-use scopes. Now, we have created a single-use portfolio that meets these needs—one that is on par with reusable bronchoscopes, in some areas even superior,” said Bassel Rifai, chief marketing officer at Ambu.”