# FDA Reclassifies Digital Breast Tomosynthesis System and Advances GRAIL Galleri Companion Diagnostic Review

> fda · REPORTED · 2026-08-07

The FDA's CDRH recently posted a Federal Register notice on reclassification of the Digital Breast Tomosynthesis System and announced a Molecular and Clinical Genetics Panel advisory committee meeting concerning GRAIL Inc.'s Galleri multi-cancer early detection test, signaling advancing regulatory review for both women's imaging and liquid biopsy technologies.

About FDA / CDRH: The FDA's Center for Devices and Radiological Health (CDRH) regulates medical devices and diagnostics across all healthcare sectors in the United States.

- Company: FDA / CDRH
- Sector: diagnostics
- Primary source: https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-new-news-and-updates

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Source: MedFuel Intel news monitor. Verification tier: REPORTED. Informational only, not investment advice. Corrections: media@medfuelinc.com.