FDA warns of potential risk from Hologic's devices implanted in soft tissue

Hologic, Inc. is the world leader in the design, manufacturing and marketing of diagnostic products, medical imaging systems and surgical products dedicated to women's health. Net sales break down by area of application as follows: - molecular diagnostics (46.7%): rapid diagnostic tests for human diseases detection (sexually transmitted infections, respiratory diseases, viral diseases, infectious diseases, cancers of the cervix and prostate, etc.) and fetal fibronectin; - breast health (35.5%): digital mammography and breast biopsy solutions and systems; - gynecological surgery (15%): endometrial ablation devices, minimally invasive intervention systems for the hysteroscopic elimination of targeted intrauterine diseases (including fibroids and polyps). The group also offers fluid management systems for use in hysteroscopic procedures; - bone health (2.8%): bone imaging systems, bone sonometers and osteodensitometers for bone structure and density, and osteoporotic fractures risk assessment. Net sales break down by source of revenue between sales of products (81.4%) and services (18.6%). Net sales are distributed geographically as follows: the United States (75.9%), Europe (12.9%), Asia/Pacific (6.3%) and other (4.9%).