Gynecology, obstetrics, breast and bone health are the major segments of the U.S. women’s health device market. In 2010, the market was valued at $2.3 billion, a 4.9% increase over the previous year. The main conditions dealt with by women’s health professionals in the U.S. are osteoporosis, cancer, incontinence, infertility and menstrual complications. Increasingly, sub-specialties are arising, particularly in gynecology, as urologists and oncologists move into the territory originally considered a gynecology specialty, and gynecologists move into urology and other surgery specialties.

Hologic was the market leader for women’s health devices in 2010, which was attributed to their strong presence in the digital mammography, endometrial ablation, breast biopsy and osteoporosis assessment devices markets. Hologic’s Selenia® digital mammography and NovaSure® endometrial ablation devices are highly regarded within the industry and lead the industry in market share.  

In 2010, the Hologic Selenia system was limited to taking two-dimensional images in the U.S. The device has been available in Europe, Canada and many other countries of the world as a 2D/3D device for several years. However, in February 2011 the U.S. Food and Drug Administration approved the Hologic Selenia Dimensions® system for screening and diagnosis for 2D or 2D/3D mammography.


The above information was derived from iData Research’s 2011 report “U.S. Market for Women’s Health Devices.

This report covers devices used for:

Bone densitometry:
o central and
o peripheral

Breast biopsy devices:
o spring loaded core needles
o VABB devices
o as well as breakdowns for stereotactic x-ray, ultrasound, and MRI guidance

Breast imaging:
o mammography,
o dedicated breast ultrasound,
o breast MRI coils,
o breast specific gamma imaging,
o positron emission mammography and
o breast ultrasound

OB/GYN ultrasound imaging

Fetal and neonatal monitoring:
o hospital,
o alternate and
o home-use

Assisted reproduction:
o embryo transfer catheters,
o oocyte retrieval needles,
o micropipettes, and
o reproductive media

Global endometrial ablation:
o uterine balloon therapy,
o hydrothermal ablation,
o radiofrequency ablation,
o cryoablation, and
o microwave ablation

Endometrial resection:
o monopolar and bipolar electrodes, and
o resectoscopes

Uterine fibroid embolization:
o microspheres and
o conventional PVA particles

o rigid and
o flexible


Female sterilization:
o Transcervical
o Mechanical and
o Bipolar sterilization

Female urinary incontinence slings:
o synthetic and
o non-synthetic

Pelvic floor electrical stimulation:
o home and
o office based

Fluid management:
o capital equipment and
o tubing