FDA Output
FDA Output, September 2025
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in September 2025. Updated September 30.
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Emerging Markets
The Sound of Progress: Focused Ultrasound Therapies Abound
Start-ups Cardiawave, SonoMotion, and Openwater each put their own spin on a therapeutic modality that has become a hot topic.
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ICYMI
TAVR Leaders Turn to Pulmonary Valves
Medtronic and Edwards are expanding into the much smaller transcatheter pulmonary valve replacement market. Excerpted from our recent feature article “A Passion Project”: Edwards and Medtronic Persevere Against TPVR Challenges.”