First FDA-Approved 3D Tomosynthesis (2011)
February 2011 — FDA Premarket Approval (PMA) of the Hologic Selenia Dimensions for digital breast tomosynthesis (DBT). The first commercial tomosynthesis platform in the U.S., and the regulatory event that established 3D mammography as a recognized clinical category. Other vendors followed via subsequent PMAs and 510(k) clearances; tomosynthesis became the clinical standard over the decade that followed.
What tomosynthesis does
A standard 2D mammogram is a single projection radiograph of compressed breast tissue. Overlapping tissue can mask cancers and create false positives. Tomosynthesis sweeps the X-ray tube through a limited arc (typically ±7.5° to ±25° depending on vendor) and acquires ~9–25 low-dose projections, then reconstructs thin (1 mm) "slices" through the breast. The 3D dataset reduces overlap-related masking and mimics the anatomic-localization advantage CT brought to body imaging in 1972.
Clinical impact
- Improved cancer detection — multiple multi-center trials (notably STORM, Oslo, TMIST) demonstrate higher cancer detection rates and lower recall rates in dense-breast populations versus 2D-only imaging.
- Reduced recall rate — fewer call-backs for "asymmetry" that's actually overlapping normal tissue.
- Architectural distortion — DBT is materially better than 2D for finding subtle architectural distortion that may represent invasive lobular cancer.
- Dense-breast populations benefit most; the European screening adoption pattern reflects this.
Adoption arc
- 2011 — Selenia Dimensions PMA approved.
- 2013 — C-View synthesized 2D approved — allows reading 3D paired with synthesized rather than separately-acquired 2D, eliminating the dose-doubling that paired 2D + 3D originally required.
- 2014–2017 — competitor PMAs (GE, Siemens, Fujifilm, IMS Giotto) reach market.
- 2017 — Hologic 3Dimensions succeeds Selenia Dimensions as the Hologic flagship.
- 2020s — DBT becomes the clinical standard for both screening and diagnostic mammography in the U.S.; tomo-guided biopsy reaches widespread clinical use.
Why the PMA pathway mattered
Mammography historically cleared via 510(k) under the existing 2D-FFDM predicate base. Tomosynthesis's substantially different acquisition geometry and clinical claim required PMA — full safety and effectiveness review with primary clinical-trial data. The PMA precedent shaped how subsequent vendors entered the category.
Descends to
- Hologic Selenia Dimensions
- Hologic 3Dimensions
- Hologic Affirm Prone biopsy
- GE Senographe Pristina
- Siemens MAMMOMAT Revelation
- Fujifilm ASPIRE Cristalle
- Fujifilm AMULET Innovality