# FDA Proposes Reclassification of Digital Breast Tomosynthesis Systems

> fda · REPORTED · 2026-08-13

The FDA published a Federal Register notice proposing reclassification of digital breast tomosynthesis (3D mammography) systems, a regulatory action that could affect device requirements and market access for next-generation breast imaging technology used in cancer screening. This action is relevant to the broader women's health and breast cancer survivorship screening landscape.

About FDA / Digital Breast Tomosynthesis: Digital breast tomosynthesis systems are FDA-regulated medical imaging devices that create three-dimensional mammography images to improve detection of breast cancer, particularly in women with dense breast tissue.

- Company: FDA / Digital Breast Tomosynthesis
- Sector: medical devices
- Primary source: https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-new-news-and-events

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