Regulatory & Reimbursement
FDA Output, October 2025
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in October 2025. Updated October 27.
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Video Interviews
Next-Gen Disrupters: Tyler Wanke on the Physician-Entrepreneur, Northwestern ‘Biodesign,’ and Chicagoland
An audio interview with the CEO of Madison Scientific about his entrepreneurial career, investment in medtech, and the drivers behind the companies he co-founded.
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Business Strategies
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.”