2 October 2026 · Medical Device Network
FDA approves expandable pulmonary valve for children
SurgeonsDoctors & NHSMedical businessesRegulation & claims
The FDA has approved Edwards’ Autus expandable pulmonary valve for paediatric patients. It is the first FDA-approved heart valve designed to be expanded after surgery to keep pace with a child’s growth.
Why it matters
This is a device development relevant to paediatric cardiac teams and medical device businesses. The reported approval concerns the US regulatory system, not UK authorisation.
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Summary for general information only — not legal, clinical or insurance advice.