Denmark-based medical device developer Ambu has received the US Food and Drug Administration (FDA) 510(k) regulatory clearance for its Ambu aScope 5 Broncho range.

Ambu aScope 5 Broncho is a family of fifth-generation single-use, sterile bronchoscopes for the pulmonology sector.

It has advanced imaging and design features, including a new high-resolution camera chip, which comes along with aBox 2 to deliver superior image quality.

The firm’s latest bronchoscope ensures sterility and offers high performance for medical professionals and patients alike in the bronchoscopy suite, putting patient safety at the centre of every surgery.

According to Ambu, the solution is based on advanced technology, has high mobility and is less expensive.

This makes the solution a desirable option for medical professionals who need to perform bronchoscopies in a variety of care settings, including operating rooms, critical care units, and emergency rooms.

The release of aScope 5 Broncho family aligns with Ambu’s goal of creating the most extensive single-use visualisation portfolio in pulmonology.

Ambu chief marketing officer Bassel Rifai said: “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.”

With the launch, Ambu said that it is now at the forefront of the introduction of single-use endoscopes into the bronchoscopy suite.

The company announced the European regulatory clearance for aScope 5 Broncho range in May this year.

It will now aim to commercialise the aScope 5 Broncho and the full high definition Ambu aBox 2 processing unit in Europe in addition to the US.