Hologic
Specialist manufacturer of women's health diagnostics and breast imaging systems.
Updated Jul 1, 2026
Headquartered in United States
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Overview
About Hologic
Hologic focuses on women's health, manufacturing breast imaging and mammography systems alongside diagnostic testing products used in screening and surgical settings.
Products
- Breast imaging & mammography systems
- Diagnostic testing for women's health
Markets Served
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Related
Certifications
ISO 13485
The international quality management system standard specific to medical device manufacturers, referenced by most major regulators.
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CE Mark
The conformity mark required to sell medical devices in the EU/EEA, issued once a device meets EU MDR or IVDR requirements.
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FDA 510(k) / PMA
US market authorization for medical devices via the FDA's 510(k), De Novo, or PMA pathways.
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Related
Regulatory Pathways
Opportunity Marketplace
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