Health · Science · Policy
Drug and device approvals
FDA, EMA and NMPA decisions and review timelines.
//
This week
- Edwards' pediatric heart valve receives FDA approvalEdwards Lifesciences' adjustable heart valve for children has received FDA approval, potentially reducing the need for multiple open-heart surgeries as the child grows.StableHealth1 sources · 3 evidence2026-10-02 23:27
- FDA Approves First Heart Valve That Grows with PatientsThe FDA has approved the Autus Size-Adjustable Valve, the first heart valve designed to expand after implantation, benefiting children with certain heart defects.Stable1 sources · 2 evidence2026-10-03 07:20
2 verified changes this week.
Daily activity
New
Signals in this topic
- 01HeartSciences Receives FDA 510(k) Clearance for MyoVista® wavECG DeviceHeartSciences Inc. received FDA 510(k) clearance for its MyoVista® wavECG device, allowing it to be used for 12-lead resting ECG in hospitals and healthcare facilities. The clearance does not include an AI-ECG algorithm, and the company plans to evaluate its options for commercialization.Technology announcement2026-10-06 20:30
- 02Edwards' pediatric heart valve receives FDA approvalEdwards Lifesciences' adjustable heart valve for children has received FDA approval, potentially reducing the need for multiple open-heart surgeries as the child grows.Technology announcement2026-10-02 23:27
- 03FDA Approves First Heart Valve That Grows with PatientsThe FDA has approved the Autus Size-Adjustable Valve, the first heart valve designed to expand after implantation, benefiting children with certain heart defects.Technology announcement2026-10-03 07:20