systemHologicMammography

Hologic Affirm Prone Biopsy System

Manufacturer: Hologic · Modality: Mammography

Dedicated prone stereotactic and tomosynthesis-guided breast biopsy platform. First dedicated prone biopsy table to offer both 2D stereotactic and 3D (DBT) biopsy guidance on the same system; the Affirm Prone is Hologic's prone-position sibling to the upright Affirm biopsy attachment used on Selenia Dimensions and 3Dimensions mammography systems.

Platform highlights

  • Prone patient positioning — patient lies face down on the biopsy table with the breast pendant through a cutout aperture. Prone positioning is the standard of care for many stereotactic biopsies: the breast immobilizes under gravity, patient motion and vasovagal responses are reduced, and the operator has 360° working access around the breast.
  • 360° needle access — fully integrated C-arm with a built-in lateral needle approach. Targets that are difficult to reach from a single entry angle on upright biopsy can be approached from any clock position.
  • Stereotactic + tomosynthesis guidance — 2D stereotactic (paired angled acquisitions for depth triangulation) and DBT (tomosynthesis sweep for in-plane lesion localization) on the same gantry. DBT-guided biopsy resolves lesions that are conspicuous only on tomosynthesis (architectural distortion, subtle masses).
  • Large field of view — Hologic product positioning cites a FOV several times larger than legacy-generation prone biopsy systems, enabling targets that previously required upright biopsy or repositioning.
  • Automated workflow — automated tube-head motion, pre-programmed needle parameters, and one-click targeting reduce manual error and shorten procedure time.
  • Integration with biopsy devices — supports Hologic's ATEC vacuum-assisted biopsy system as a standard workflow path; compatible with other standard biopsy devices.

Specs

  • Dedicated prone biopsy table with 360° C-arm rotation
  • Imaging modes: 2D stereotactic, DBT-guided (3D)
  • Integrated lateral needle approach
  • Tungsten target, amorphous-selenium direct-conversion detector (Hologic a-Se lineage shared with Selenia / 3Dimensions)
  • Automated tube-head motion
  • Compatible with ATEC and other standard vacuum / core biopsy devices

Clinical positioning

  • Stereotactic biopsy of calcifications — the primary use case for 2D stereotactic guidance.
  • DBT-detected architectural distortion / subtle masses — DBT guidance is clinically meaningful where the lesion is conspicuous only on tomosynthesis.
  • Difficult-access lesions — posterior chest wall, deep medial, lateral-posterior targets benefit from the 360° access and prone geometry.
  • High-volume screening programs — facilities with a DBT-forward screening protocol (3Dimensions or Selenia Dimensions) route their DBT-guided biopsies to Affirm Prone.

Relationship to siblings

  • Upright Affirm biopsy attachment — adapter that turns Selenia Dimensions or 3Dimensions into an upright biopsy gantry. Upright workflow suits claustrophobic / mobility-limited patients; prone remains standard for longer biopsies and difficult-access lesions.
  • Predecessor-class prone biopsy tables (Lorad StereoLoc / MultiCare) — earlier-generation dedicated prone tables Hologic's Affirm Prone displaced.

Regulatory

  • FDA 510(k) cleared (FDA 510(k)).
  • MQSA does not directly regulate biopsy (MQSA scope is screening/diagnostic mammography); facility accreditation still typically includes biopsy workflow QA via ACR accreditation.

Related