Natera wins FDA Breakthrough Device status for multi-cancer blood test as NTRA climbs
Natera’s multi-cancer blood test wins FDA Breakthrough Device status after a 12-cancer review, but full performance data remain undisclosed.
Medical Devices & Diagnostics
Medical Devices & Diagnostics
Why GRAIL stock exploded after FDA documents on Galleri cancer blood test
GRAIL shares recorded their strongest session in more than a year after FDA reviewers raised no major analytical or primary safety concerns ahead of a September 23 advisory committee vote on Galleri, the blood test designed to screen adults for signals from more than 50 cancers.
Medical Devices & Diagnostics
FDA panel to review GRAIL Galleri cancer blood test after pivotal NHS trial misses primary endpoint
GRAIL, Inc. will face a potentially defining regulatory examination on September 23, 2026, when outside advisers to the United States Food and Drug Administration review the premarket approval application for its Galleri multi-cancer early detection blood test. The FDA’s Molecular and Clinical Genetics Panel is scheduled to discuss and vote on whether the available evidence
Medical Devices & Diagnostics
Can Junction’s GRAIL tie-up do what clinical data alone could not for Galleri adoption?
Junction and GRAIL are expanding Galleri access, but can workflow integration overcome regulatory, reimbursement, and adoption hurdles? Read more.