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News about "Breakthrough Device Designation"
Grail Submits Final PMA Module to FDA for Galleri Multi-Cancer Early Detection Test
Grail files the final Premarket Approval module with the FDA for its Breakthrough Device-designated Galleri test, supported by data from over 25,000 participants in PATHFINDER 2 and the NHS-Galleri trial.
Breakthrough Device Designation | 30/01/2026 | By News Bureau | 398
Beckman Coulter Launches RUO Immunoassay Test
Access BD-Tau, along with Beckman Coulter Diagnostics's expanding portfolio of neuro-degenerative disease RUO assays, is available for use on the ground-breaking DxI 9000 Immunoassay Analyzer and Access 2 Analyzer.
Breakthrough Device Designation | 12/09/2025 | By Dineshwori | 171
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