History of Innovation

    1985

    FDA clears the first nucleic acid test.

    1985

    FDA clears the first nucleic acid test.

    1987

    Hologic introduces the first dual-energy X-ray absorptiometry system for evaluating osteoporosis.

    1987

    Hologic introduces the first dual-energy X-ray absorptiometry system for evaluating osteoporosis.

    1988

    FDA clears the first molecular diagnostic test kit for a sexually transmitted infection.

    1988

    FDA clears the first molecular diagnostic test kit for a sexually transmitted infection.

    1995

    FDA approves the Rapid fFN® test.

    1995

    FDA approves the Rapid fFN® test.

    1996

    FDA approves the ThinPrep® Pap test, liquid-based cytology for cervical cancer screening.

    1996

    FDA approves the ThinPrep® Pap test, liquid-based cytology for cervical cancer screening.

    2001

    FDA approves the NovaSure® endometrial ablation treatment for abnormal uterine bleeding (AUB).

    2001

    FDA approves the NovaSure® endometrial ablation treatment for abnormal uterine bleeding (AUB).

    2002

    FDA approves the Selenia® mammography system–the beginning of a new era in breast cancer screening.

    2002

    FDA approves the Selenia® mammography system–the beginning of a new era in breast cancer screening.

    2002

    FDA approves the first nucleic acid test for screening donated blood prior to transfusion.  

    *Procleix and Ultrio are registered trademarks of Grifols, SA.

    2002

    FDA approves the first nucleic acid test for screening donated blood prior to transfusion.  

    *Procleix and Ultrio are registered trademarks of Grifols, SA.

    2003

    Release of the Tigris® DTS® system for automated screening of sexually transmitted infections (STIs).

    2003

    Release of the Tigris® DTS® system for automated screening of sexually transmitted infections (STIs).

    2008

    FDA approves the Procleix® Ultrio®* triplex blood screening assay for HIV-1, hepatitis B and C.

    *Procleix and Ultrio are registered trademarks of Grifols, SA.

    2008

    FDA approves the Procleix® Ultrio®* triplex blood screening assay for HIV-1, hepatitis B and C.

    *Procleix and Ultrio are registered trademarks of Grifols, SA.

    2011

    FDA approves the breakthrough Selenia Dimensions® digital tomosynthesis system with the Hologic 3D Mammography™ exam.

    2011

    FDA approves the breakthrough Selenia Dimensions® digital tomosynthesis system with the Hologic 3D Mammography™ exam.

    2012

    FDA clears the Panther® system, an automated, integrated molecular platform, for use with the Aptima Combo 2® assay.

    2012

    FDA clears the Panther® system, an automated, integrated molecular platform, for use with the Aptima Combo 2® assay.

    2014

    FDA clears the use of the bone densitometer for assessing three critical health problems, including osteoporosis

    2014

    FDA clears the use of the bone densitometer for assessing three critical health problems, including osteoporosis

    2015

    CE marked virology portfolio, including Aptima® HIV, HCV and HBV assays, along with the Aptima® M. genitalium assay.

    2015

    CE marked virology portfolio, including Aptima® HIV, HCV and HBV assays, along with the Aptima® M. genitalium assay.

    2016

    FDA clears the new Affirm® prone biopsy system.

    2016

    FDA clears the new Affirm® prone biopsy system.

    2017

    FDA approves Aptima® HIV-1 Quant assay, Aptima® HCV Quant DX assay, and the Aptima® HSV 1 & 2 assay. The Panther Fusion® respiratory assays were approved on the Panther Fusion system.

    2017

    FDA approves Aptima® HIV-1 Quant assay, Aptima® HCV Quant DX assay, and the Aptima® HSV 1 & 2 assay. The Panther Fusion® respiratory assays were approved on the Panther Fusion system.

    2017

    The Brevera® breast biopsy system with CorLumina® imaging technology combines tissue acquisition, real-time imaging, verification and advanced tissue handling.

    2017

    The Brevera® breast biopsy system with CorLumina® imaging technology combines tissue acquisition, real-time imaging, verification and advanced tissue handling.

    2018

    FDA clears Clarity HD high-resolution 3D™ imaging and the SmartCurve™ breast stabilization system, providing superior image quality and a clinically proven solution for a more comfortable mammogram.

    2018

    FDA clears Clarity HD high-resolution 3D™ imaging and the SmartCurve™ breast stabilization system, providing superior image quality and a clinically proven solution for a more comfortable mammogram.

    2019

    The FDA grants clearance to the new Aptima® BV and Aptima® CV/VT assays, which provide an accurate and objective method for diagnosing vaginitis.

    2019

    The FDA grants clearance to the new Aptima® BV and Aptima® CV/VT assays, which provide an accurate and objective method for diagnosing vaginitis.

    2020

    FDA grants Emergency Use Authorization (EUA) for the Panther Fusion® SARS-CoV-2 and Aptima® SARS-CoV-2 assays, molecular diagnostic tests detecting the novel coronavirus.

    2020

    FDA grants Emergency Use Authorization (EUA) for the Panther Fusion® SARS-CoV-2 and Aptima® SARS-CoV-2 assays, molecular diagnostic tests detecting the novel coronavirus.