Women's imaging vendor Hologic of Bedford, MA, has received CE Mark approval for its Celero vacuum-assisted spring-loaded core biopsy device.
The company is targeting Celero for the ultrasound market and also received CE Mark approval for the CeleroMark and CeleroMark-2S biopsy site identifiers, as well as the Celero Intro-12 introducer, clearing the way for sales in the European Union and all countries that recognize the CE Mark.
Hologic also is registering Celero in Latin and South America, the Middle East, and Asia. Celero received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in April 2007.
Related Reading
Road to RSNA, CAD, Hologic, October 30, 2008
Road to RSNA, Women's Imaging, Hologic, October 28, 2008
Hologic gets clearance for breast software, October 1, 2008
Study: APBI compares favorably to standard RT, October 1, 2008
Hologic gets FDA nod for FRAX, September 9, 2008
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![Overview of the study design. (A) The fully automated deep learning framework was developed to estimate body composition (BC) (defined as subcutaneous adipose tissue [SAT] in liters; visceral adipose tissue [VAT] in liters; skeletal muscle [SM] in liters; SM fat fraction [SMFF] as a percentage; and intramuscular adipose tissue [IMAT] in deciliters) from MRI. The fully automated framework comprised one model (model 1) to quantify different BC measures (SAT, VAT, SM, SMFF, and IMAT) as three-dimensional (3D) measures from whole-body MRI scans. The second model (model 2) was trained to identify standardized anatomic landmarks along the craniocaudal body axis (z coordinate field), which allowed for subdividing the whole-body measures into different subregions typically examined on clinical routine MRI scans (chest, abdomen, and pelvis). (B) BC was quantified from whole-body MRI in over 66,000 individuals from two large population-based cohort studies, the UK Biobank (UKB) (36,317 individuals) and the German National Cohort (NAKO) (30,291 individuals). Bar graphs show age distribution by sex and cohort. BMI = body mass index. (C) After the performance assessment of the fully automated framework, the change in BC measures, distributions, and profiles across age decades were investigated. Age-, sex-, and height-adjusted body composition reference curves were calculated and made publicly available in a web-based z-score calculator (https://circ-ml.github.io).](https://img.auntminnieeurope.com/mindful/smg/workspaces/default/uploads/2026/05/body-comp.XgAjTfPj1W.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
