Ambu wins FDA and CE clearance for two bronchoscopes
Two Ambu bronchoscopes received FDA 510(k) clearance and CE marking for pediatric airway procedures. A U.S. and European launch is expected in early 2027.
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what happened
Reuters reports that Ambu A/S has secured FDA 510(k) clearance and CE marking for two bronchoscopes in its Ambu aScope 5 Broncho portfolio. The devices are approved for use in pediatric airway procedures.
The company expects to begin a commercial launch across the U.S. and Europe in early 2027.
why it matters
The clearances allow Ambu to prepare the two devices for pediatric procedures in the U.S. and Europe. The planned early-2027 launch provides the next timeline marker for the portfolio’s commercial rollout.
instruments
sources
- Ambu Says Two Bronchoscopes Get FDA Clearance, CE Mark For Use In Pediatric Airway Procedures — Reuters, 12 October 2026 at 10:59 UTC
prepared by the newsmetry newsroom with ai assistance from the sources listed below. not investment advice.
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