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2026 FDA Medical Device Calendar

Upcoming medical-device FDA milestones — PMA, 510(k), De Novo submissions/decisions and pivotal device readouts. Company, product, indication and the source filing. Tap any row for the source.
PDUFA datesTrial readoutsDevices
July 2026
DRTS · 2026-07-21
Alpha DaRT + pembrolizumab — Recurrent/metastatic HNSCC (AHNS)
H2 2026 (est.)
NPCE · H2 2026
RNS System (NAUTILUS) — Epilepsy
GRAL · H2 2026
Galleri (PATHFINDER 2) — Multi-cancer early detection
Q2 2026 (est.)
NPCE · Q2 2026
ECoG Assistant / PDMS — Epilepsy
BWAY · Q2 2026
Deep TMS — Post-traumatic stress disorder (PTSD)
VRAX · Q2 2026
ViraxImmune platform — T-cell dysfunction (long COVID/PTLD/ME-CFS)
2026 (est.)
ICU · 2026
SCD (NEUTRALIZE-AKI) — Adult acute kidney injury on CKRT
PROF · 2026
TULSA (Level 1 CAPTAIN) — Prostate
NUWE · 2026
Aquadex SmartFlow (REVERSE-HF) — Ultrafiltration for hypervolemia
2027 (est.)
BJDX · 2027
Symphony IL-6 Test (SYMON) — Sepsis patient care and monitoring
10 upcoming device milestones. Sources: company filings / curated device seed. Many device dates are quarter/half-year windows.