FDA Output
FDA Output, March 2026
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in March 2026. Updated March 30.
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Business Strategies
Ventric Health: Expanding Access to Early Heart Failure Detection
Primary care clinicians are most likely to encounter patients harboring early, subclinical cardiac changes. Historically, however, they have lacked objective tools to identify such patients. Now Ventric Health offers an FDA-cleared screening tool called Vivio, to catch early signs of heart failure, to interrupt the course of this degenerative condition. A companion article to "Innovating Heart Failure: Start-Ups Harness Natural Pathways."
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Pathways’ Pick of the Week
Pathways' Pick of the Week: FDA Launches a New Framework for FDA Inspections
FDA’s new Quality Management System Regulation takes effect. Excerpted from Pathways’ Pick of the Week March 4: FDA Adopts QMSR, EU Harmonizes Standards, South Korea Spotlights Innovation.