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FDA panel backs GRAIL's Galleri on a 6 to 4 effectiveness vote TriSalus clears TriNav Advance, its fourth pressure-enabled infusion device Anaconda Biomed raises $56M to finish a 327-patient stroke trial FDA issues an early alert on Impella controllers that miss purge cassettes HighLife raises 80 million euros for a mitral valve CE marked in January Xenix Medical clears the Riva Anchor for sacroiliac fusion at the base of a lumbar construct Dialybrid raises 15 million euros as its silk polyurethane dialysis graft reaches a first patient CMS posts preliminary 2027 lab rates and cuts more than 1,100 test codes FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel backs GRAIL's Galleri on a 6 to 4 effectiveness vote TriSalus clears TriNav Advance, its fourth pressure-enabled infusion device Anaconda Biomed raises $56M to finish a 327-patient stroke trial FDA issues an early alert on Impella controllers that miss purge cassettes HighLife raises 80 million euros for a mitral valve CE marked in January Xenix Medical clears the Riva Anchor for sacroiliac fusion at the base of a lumbar construct Dialybrid raises 15 million euros as its silk polyurethane dialysis graft reaches a first patient CMS posts preliminary 2027 lab rates and cuts more than 1,100 test codes FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US

Advisory panel

FDA panel backs GRAIL's Galleri on a 6 to 4 effectiveness vote

MedDevice Startups Staff · 16 hrs ago · 2 min read · Via GRAIL

An FDA advisory panel voted in favor of GRAIL's Galleri multi-cancer early detection test on September 23. The Molecular and Clinical Genetics Devices Panel went 10 to 0 that the test is safe, 6 to 4 that it is effective, and 7 to 2 with one abstention that its benefits outweigh its risks.

GRAIL filed the PMA on January 29, 2026. It asks for approval to screen adults aged 50 and older for multiple cancers from a single blood draw. The company pointed the panel to PATHFINDER 2 in North America and the NHS-Galleri trial in England, and said Galleri has detected roughly four to seven times more cancers than standard of care alone, most of them at earlier stages.

The effectiveness split is the number to watch. FDA is not bound by panel votes, and four dissents on the central question leave reviewers room to attach postmarket conditions or narrow the indication. A decision is expected in the coming months.

Questions & Answers

How did the FDA advisory panel vote on GRAIL's Galleri test?

On September 23, 2026 the FDA Molecular and Clinical Genetics Devices Panel voted 10 to 0 that GRAIL's Galleri test is safe, 6 to 4 that it is effective, and 7 to 2 with one abstention that its benefits outweigh its risks.

What indication is GRAIL seeking for the Galleri multi-cancer early detection test?

GRAIL's PMA asks FDA to approve Galleri for screening adults aged 50 and older for the early detection of multiple types of cancer from a blood draw. GRAIL filed the application on January 29, 2026.

Does FDA have to follow the advisory panel recommendation on Galleri?

No. FDA considers advisory panel votes but is not bound by them. A final decision on GRAIL's Galleri PMA is expected in the coming months.

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