FDA daily for Monday, August 31, 2026
In this issue: 1 approval and 8 device decisions.
Drug and biologic approvals
FDA date:On Mon, Aug 24 FDA approved no new applications and 1 supplement to existing ones.
- IMAAVY
JANSSEN BIOTECH · NIPOCALIMAB-AAHU
Device clearances and approvals
FDA date:FDA decided 4 510(k)s and 4 PMA decisions on Mon, Aug 17.
- MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)
ImpediMed Limited · Cardiovascular
- MagicScan-1.5, GreenMR Serenity 1.5T
Xingaoyi Medical Equipment Co.,Ltd · Radiology
- KBA3D (v2.4.0)
S.M.A.I.O · Radiology
FDA did not answer for Drug shortages, Food and supplement recalls, Device recalls, Drug recalls, Labels while this issue was written; those sections will fill in on a later visit.
How the FDA daily is written
Every issue is written from FDA's public data (openFDA) and nothing else: the counts, names, firms and reasons are FDA's own. openFDA posts each kind of record on its own delay, so each section covers one FDA date and says which. Shortages cover yesterday; approvals, drug and device recalls, and food and supplement recalls cover a week ago; device clearances and label changes cover two weeks ago. Every FDA date appears in exactly one issue. Complete response letters appear the day after FDA publishes a batch.
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