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2026 FDA Medical Device Calendar

Updated ยทnext FDA decision on the 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.)
VRAX · Q2 2026
ViraxImmune platform: T-cell dysfunction (long COVID/PTLD/ME-CFS)
BWAY · Q2 2026
Deep TMS: Post-traumatic stress disorder (PTSD)
NPCE · Q2 2026
ECoG Assistant / PDMS: Epilepsy
2026 (est.)
PROF · 2026
TULSA (Level 1 CAPTAIN): Prostate
ICU · 2026
SCD (NEUTRALIZE-AKI): Adult acute kidney injury on CKRT
NUWE · 2026
Aquadex SmartFlow (REVERSE-HF): Ultrafiltration for hypervolemia
Q2 2027 (est.)
OBIO · Q2 2027
AVIM therapy (BACKBEAT): Uncontrolled hypertension
2027 (est.)
BJDX · 2027
Symphony IL-6 Test (SYMON): Sepsis patient care and monitoring
11 upcoming device milestones. Sources: company filings / curated device seed. Many device dates are quarter/half-year windows.