AMBU EXTENDS RESPIRATORY OFFERING INTO PEDIATRIC AIRWAY PROCEDURES

Copenhagen, Denmark, 12 October 2026 – Ambu, the global market leader in single-use endoscopy, today announces that two bronchoscopes within its Ambu aScope 5 Broncho portfolio have received FDA 510(k) clearance and CE mark for use in pediatric airway procedures. The pediatric-indicated bronchoscopes are not yet commercially available.

The new indication extends Ambu’s bronchoscopy portfolio into pediatric care, strengthening the Company’s Respiratory offering across additional patient populations and clinical settings, including pediatric intensive care units, children’s hospitals, operating rooms, and emergency departments.

The two bronchoscopes, as well as a Sampler Set, with expanded pediatric indication are:

• aScope 5 Broncho 2.7/1.2: For patients aged six months and older (the world’s first bronchoscope, including reusables, with a working channel for patients aged six months and older)
• aScope 5 Broncho 4.2/2.2: For patients aged six years and older
• aScope 5 Broncho 4.2/2.2 Sampler Set: Cleared for patients aged six years and older

Due to lower procedure volumes and the specialized nature of pediatric care, clinicians often have limited access to pediatric bronchoscopes. When treating a particularly vulnerable patient population like pediatric patients, lack of bronchoscope availability can create workflow challenges and add pressure on caregiver teams. As a result, hospitals increasingly seek bronchoscopy solutions that can support both adult and pediatric patients, enabling them to address a broader range of clinical needs with a single solution.

By expanding into pediatric care, Ambu can now provide clinicians with immediate access to single-use bronchoscopes across both adult and pediatric patients, improving workflow efficiency and flexibility across care settings. Overall, the new pediatric indication strengthens the breadth of Ambu’s Respiratory offering and increases the relevance of the Company’s broader portfolio across both adult and pediatric care.

“This is an important step in extending the reach and value of our leading single-use Respiratory offering, in line with our ZOOM AHEAD strategy,” says Britt Meelby Jensen, CEO of Ambu. “With the pediatric indication, we can support clinicians across more procedures, patient groups, and care settings while reinforcing the value single-use solutions bring through improved availability, workflow efficiency, and patient care.”

Ambu’s redesigned (internal design enhancements) pediatric bronchoscopy solutions are not yet available. Current Ambu aScope 5 Broncho solutions on the market are not cleared for pediatric use.

Ambu expects to initiate a commercial launch across the U.S. and Europe in early 2027.

AMBU’S RESPIRATORY OFFERING Endoscopes: Ambu® aScope™ 5 Broncho portfolio (four sizes): HD 5.6/2.8 – adult patients HD 5.0/2.2 – adult patients 4.2/2.2 – adult and pediatric patients from six years and older 2.7/1.2 – adult and pediatric patients from six months and older Ambu® aScope™ 4 Broncho portfolio (three sizes): Slim Regular Large EndoIntelligence™: Ambu® aView™ 2 Advance Ambu® aBox™ 2 Video laryngoscopy and one-lung ventilation: Ambu® SureSight™ Connect Ambu® SureSight™ Mobile Ambu® VivaSight™ 2 DLT Ambu® VivaSight™ 2 SLT Accessories: Ambu® aScope™ BronchoSampler Ambu® aScope™ Sampler Set Ambu® aCart™ Compact