Regulatory & Reimbursement
FDA Output, September 2026
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in September 2026. Updated September 30.
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Start-Ups to Watch
VahatiCor: On the Trail of Microvascular Disease
Coronary microvascular disease can contribute to major cardiovascular pathology, but there are no approved disease-modifying therapies. On the hunt for a new solution, VahatiCor is pursuing a new device that narrows coronary sinus flow to improve perfusion in the microvascular network.
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ICYMI
Despite AI’s Allure, Medtech Investors Stay Grounded
Medtech investing has maintained its momentum from 2025 through 2026, according to PwC’s latest medtech deals outlook. Excerpted from our recent feature, “As Dollars Chase AI Dream, Investors Stay Grounded.”