Regulatory & Reimbursement
FDA Output, June 2026
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in June 2026. Updated June 23.
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Start-Ups
The Digest June 2026
In this month's news, FDA clearances for several imaging technologies, Resmed expands into sleep medicine by buying Noctrix Health, TAP pilot progress, and more.
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Pathways’ Pick of the Week
Pathways' Pick of the Week: Bypassing 510(k)s
FDA plans to exempt more unclassified devices from premarket notification requirements. Excerpted from Pathways’ Picks June 11: Opposition to EU WET Exemptions, Medicare Coverage Updates, and More.