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Ambu gets FDA clearance for single-use bronchoscope

Ambu announced European regulatory clearance in May and will now proceed with commercialization of the aScope 5 Broncho and the full high definition Ambu aBoxTM 2 processing unit in Europe as well as in the United States. (Submitted photo)

Columbia-based Ambu Inc. on Wednesday announced the Ambu aScopeTM 5 Broncho, a family of single-use, sterile bronchoscopes, has received 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA).

Ambu announced European regulatory clearance in May and will now proceed with commercialization of the aScope 5 Broncho and the full high definition Ambu aBoxTM 2 processing unit in Europe as well as in the United States.

With the aScope 5 Broncho, Ambu now leads the entry of single-use endoscopes in the bronchoscopy suite, a market segment known for its complex medical procedures — procedures that require scopes of high-performance image quality and handling. To enter this market, the aScope 5 Broncho family has advanced imaging and design features, including a new high-resolution camera chip, which, in combination with the aBox 2, delivers superior image quality.

The launch of the aScope 5 Broncho family follows Ambu’s ambition of establishing the most comprehensive single-use visualization portfolio within pulmonology.