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Home » Ambu wins FDA clearance for 5th-gen single-use bronchoscope

Ambu wins FDA clearance for 5th-gen single-use bronchoscope

July 27, 2022 By Sean Whooley

Ambu aScope 5 Broncho bronchoscope
[Image from Ambu]
Ambu announced today that it received FDA 510(k) clearance for its aScope 5 Broncho family of sterile, single-use bronchoscopes.

Ballerup, Denmark–based Ambu designed the aScope Broncho with advanced imaging and design features, including a new high-resolution camera chip.

The company received European regulatory clearance in May of this year and said in a news release that it will proceed with the commercialization of aScope 5 Broncho, as well as the full high-definition Ambu aBox 2 processing unit in both Europe and the U.S. following the latest regulatory nod.

Ambu said that, with the advanced imaging and design features including the high-resolution camera chip, aScope 5 Broncho delivers superior image quality in combination with the aBox 2.

The fifth-generation bronchoscope offers sterility along with high performance, plus advanced technology, portability and cost-effectiveness, the company said. Its versatility ranges across care settings, including 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,” said Bassel Rifai, chief marketing officer at Ambu. “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.”

Dr. Ashutosh Sachdeva , director of the 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 added that Ambu’s latest offering represents a large step forward in the bronchoscopy space.

“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,” Sachdeva said. “The way I see where the field is going, I think this is a bronchoscope of the future.”

 

Ambu disclosed that Dr. Sachdeva is a paid consultant of Ambu A/S. He has not been compensated for his quote in the company’s press release.

Filed Under: 510(k), Business/Financial News, Featured, Food & Drug Administration (FDA), Imaging, Regulatory/Compliance Tagged With: Ambu

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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